Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for 

. He is also the executive producer of two podcasts: 

. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

At week 16, PASI 75 was reached by 51.8% and 57.4% of patients on prifemilast 10 mg and 20 mg, compared with 10.8% on placebo.

Responses separated from placebo by week 2 and were sustained through week 52.

Most adverse events were mild to moderate, with few discontinuations.

Prifemilast, an investigational oral inhibitor selective for phosphodiesterase 4B (PDE4B), produced PASI 75 response rates about 5 times higher than placebo at week 16 in adults with moderate to severe 

. The benefits appeared by week 2 and lasted through 1 year.¹ The phase 2 and 3 findings, both from trials conducted in China, were presented at the 

2026 Fall Clinical Dermatology Conference

Adverse events affecting the gastrointestinal tract and central nervous system (CNS) have long limited the tolerability of the PDE4 inhibitor class.³ Prifemilast (HPP737), developed by Newsoara Biopharma, has a molecular structure designed to limit CNS penetration and slow absorption, with the aim of reducing CNS-related adverse events.¹ A previous phase 1 study described its pharmacokinetics and tolerability in healthy participants.²

The poster was presented by Lin Cai of Peking University People’s Hospital, with co-investigators from 12 Chinese hospitals and Newsoara Biopharma.¹

What Did the Phase 2 Dose-Ranging Trial Show?

The multicenter phase 2 trial randomly assigned 123 adults 1:1:1:1 to once-daily prifemilast 6 mg, 10 mg or 20 mg (n = 31 each) or placebo (n = 30) for 12 weeks.¹ Participants had a mean age of 40.2 years, and 79.7% were male.

At week 12, all 3 prifemilast doses produced higher PASI 75 and PASI 90 response rates than placebo, and the response increased with dose. The differences were statistically significant for the 10 mg and 20 mg doses (

 < .05).¹ Of 239 adverse events reported in 84 patients, most were grade 1 or 2 and resolved by the end of the study.

The 2-part phase 3 trial randomly assigned 505 adults 1:1:1 to once-daily prifemilast 10 mg (n = 170), prifemilast 20 mg (n = 169) or placebo (n = 166) for 16 weeks.¹ All participants then received prifemilast 10 mg or 20 mg during a 36-week extension. The mean age was 46.3 years, and 79.2% of participants were male.

At week 16, PASI 75 was achieved by 51.8% (88/170) of subjects on 10 mg and 57.4% (97/169) of those on 20 mg, compared with 10.8% (18/166) of those being treated with a placebo (

 < .0001 for both doses).¹ PASI and static Physician’s Global Assessment responses were found to have separated from placebo as early as week 2.

By week 8, those evaluated also saw clinically meaningful improvements in Dermatology Life Quality Index scores, and the efficacy gains held through week 52.¹

What Is the Safety Profile of Prifemilast?

Through week 52, most adverse events were grade 1 or 2.¹ Discontinuations due to adverse events occurred at a pooled rate of 2.8 per 100 patient-years.

Both trials enrolled patients only in China, and the abstract doesn’t report rates of individual adverse events, including gastrointestinal effects. The authors concluded that the results support further development of prifemilast as an oral therapy for psoriasis, ulcerative colitis and Crohn’s disease.¹

Editor's Note: This summary has been edited for grammar and clarity using artificial intelligence tools.

Cai L, Chen K, Li L, et al. Prifemilast, an oral phosphodiesterase 4B (PDE4B)-selective inhibitor, demonstrates rapid and durable efficacy with a favorable tolerability and safety profile in moderate to severe plaque psoriasis: results from phase 2 and 3 trials. Presented at: 2026 Fall Clinical Dermatology Conference; Las Vegas, NV. 

Ye L, Wang L, Tao X, et al. Pharmacokinetics, safety and tolerability of HPP737, a novel PDE4 inhibitor, in healthy Chinese participants: phase I study. 

. 2026;20:598997. doi:10.2147/DDDT.S598997.

Rabe KF. Update on roflumilast, a phosphodiesterase 4 inhibitor for the treatment of chronic obstructive pulmonary disease. 

. 2011;163(1):53-67. doi:10.1111/j.1476-5381.2011.01218.x.

Articles

Oral prifemilast, a PDE4B-selective inhibitor, led to PASI 75 attainment in up to 57.4% of those with psoriasis at week 16 vs 10.8% with placebo.

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Prifemilast Achieves PASI 75 in Up to 57% of Patients With Psoriasis

Michael Wechsler, MD, of National Jewish Health.

An integrated post hoc analysis of the phase 3 SWIFT-1/-2 trials and the 52-week AGILE open-label extension, presented at the 

 in Phoenix, found patients in clinical remission with twice-yearly depemokimab (Exdensur) at the end of year 1 had fewer 

 exacerbations and greater lung function gains in year 2.¹,² Of 405 patients in the remission analysis set, 30% reached remission at the end of year 1, and 59% of these patients maintained it at the end of year 2.¹

Remission required no exacerbations across 52 weeks, no maintenance oral corticosteroids in the final 90 days, an Asthma Control Questionnaire (ACQ)-5 score < 1.5, and a forced expiratory volume in 1 second (FEV1) change from baseline of ≥ 0 mL.¹ During year 2, the annualized exacerbation rate was 0.19 (95% CI, 0.12–0.29) among patients in remission at year 1 vs. 0.69 (95% CI, 0.57–0.82) among patients not in remission.¹ From SWIFT-1/-2 baseline to the end of year 2, pre-bronchodilator FEV1 improved by 379 mL (95% CI, 301–458) vs 85 mL (95% CI, 33–137), and ACQ-5 score changed by −1.34 vs −0.71, respectively.¹

Depemokimab, an ultra-long-acting interleukin-5 (IL-5) antagonist, received FDA approval in December 2025 as add-on maintenance treatment for severe asthma with an eosinophilic phenotype in patients aged ≥ 12 years.

 Targeted biologics have made clinical remission a treatment goal in severe asthma, leaving clinicians to weigh how well remission holds once a patient reaches it.

In the following Q&A, Michael E. Wechsler, MD, professor of medicine and director of The Cohen Family Asthma Institute at National Jewish Health, spoke with 

at CHEST 2026 about the durability of remission, twice-yearly dosing, treatment decisions for patients who fall short of remission, and how depemokimab fits among existing biologics.

Q&A: Asthma Remission from Year 1 to Year 2 with Depemokimab

Why is clinical remission now a realistic goal in severe asthma?

Depemokimab Year 1 Remission Linked to Better Year 2 Asthma Outcomes

 We now have very effective therapies to treat patients with severe asthma. We are using targeted biologic therapies that target specific pathways involved in type 2 inflammation, and that's allowed us to get many of our patients into remission. By remission, we are talking about having no exacerbations, no oral corticosteroids, having normalized symptoms, and really achieving some improvement in FEV1 in lung function.

What does twice-yearly dosing change for patients and clinicians?

 When we offer patients twice-yearly dosing, it means that there's less of an impact on their day-to-day lives. They're not thinking about taking their medications.

If you have to take a drug every 2 weeks, every 4 weeks, even every 8 weeks, it's something you have to think about all the time. With twice-yearly dosage, it's much easier for patients to be more adherent and to potentially have better outcomes in the real world.

Why ask whether year 1 remission predicts year 2?

 It's important to ask who is most likely to stay in remission, and it’s usually people who’ve attained some degree of remission in the first year. If you analyze those people, you'll find that while about 30% of patients in the overall clinical trials achieve some degree of remission. If you take those people who've achieved remission, about 60% of those people are able to stay in remission. So, it gives you increasing confidence to continue to prescribe those therapies to those patients.

How durable was remission into the second year?

 Of the patients who attained remission in the first year, about 60% of those patients were able to continue to have remission in the second year. Those patients had no exacerbations, had stable or improved lung function, had no significant symptoms during that phase, and [had] no steroid use for their asthma.

70% didn't reach remission in year 1. Should they stay on the therapy?

 With most therapies, you want to try to find the right drug for the right patient, and remission is a pretty high bar to achieve. While our ultimate goal is remission, many patients achieve some benefits, so not everyone has complete elimination of exacerbations. But about 50% of exacerbations are reduced or eliminated with biologic therapies, like depemokimab.

We need to recognize that not everyone's going to achieve remission, but they might still have benefits, and they might have benefits in terms of reduction in steroid dose, reduction in exacerbations, improvement in lung function, [and] improvement in symptoms. They may not necessarily achieve all of those, but I think achieving even any of those outcomes might have benefits for those patients.

Is this the right definition of remission?

 There are many different definitions of remission, and they take into account different thresholds. There's a big debate among experts about what remission [is], how we define remission, [and] over what duration of time [it is]. Is it 12 months? Is it 6 months? Is it 2 years or longer?

In this study, we used a 4-component definition of remission, but a 3-component definition of remission is also good.

Sometimes people start off [with] a high lung function, and if their FEV1 is 85%, they may not necessarily improve in terms of lung function. But if they have no exacerbations, whereas they had 2 exacerbations in the year prior, that is important.

Where does depemokimab fit among existing biologics?

 The addition of depemokimab into the armamentarium of biologics has been really important for us. It offers a distinct advantage in that it has every-6-month dosing. It has benefits in terms of patients with eosinophilic asthma.

It has benefits in terms of patients with chronic rhinosinusitis with nasal polyps. It's an important addition, and it's good to have a lot of options.

The way I choose a biologic for my patients is I look at the biomarker profile. I look at the comorbidities, I look at safety, I look at dosing, and all of those are important attributes that can be benefited by utilization of a drug like depemokimab.

Wechsler ME, Tacon CE, Muccino D, et al. Attainment of clinical remission with twice-yearly depemokimab in year 1 is associated with improved clinical outcomes in year 2: SWIFT/AGILE integrated analysis. Presented at: CHEST 2026; October 20, 2026; Phoenix, AZ.

Wechsler M. Depemokimab Year 1 Remission Linked to Better Year 2 Asthma Outcomes. HCPLive. Published October 21, 2026. Accessed November 3, 2026. 

https://www.hcplive.com/view/depemokimab-year-1-remission-linked-better-year-2-asthma-outcomes

Brooks A. FDA Approves Depemokimab-ulaa (Exdensur) for Severe Asthma. HCPLive. Published December 16, 2025. Accessed November 3, 2026. 

https://www.hcplive.com/view/fda-approves-depemokimab-ulaa-exdensur-for-severe-asthma

Michael Wechsler, MD, discusses SWIFT/AGILE data showing 59% of patients in remission with depemokimab at year 1 maintained it at year 2.

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

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Q&A: Asthma Remission from Year 1 To Year 2 With Depemokimab 

Raed Joundi, MD, is an assistant professor in the department of medicine at McMaster University, a scientist in the Brain Health research program at the Population Health Research Institute (PHRI), and the Anne Marie Brune/PHRI Chair in Vascular Dementia at McMaster and PHRI.

Asundexian’s improvements in stroke recurrence irrespective of infarct subtype in patients with 

 have opened up a wide range of potential future research targets for Factor XIa inhibition.

Asundexian and the Role of Factor XIa Inhibition in Secondary Stroke Prevention

 in Seoul, South Korea, by Raed Joundi, MD, assistant professor in the department of medicine at McMaster University, scientist in the Brain Health research program at the Population Health Research Institute (PHRI), and Anne Marie Brune/PHRI Chair in Vascular Dementia at McMaster and PHRI.

“There were suspicions that those with a small vessel occlusion may not respond as well to asundexian, and that’s because there are different mechanisms hypothesized for small vessel occlusion; not only thrombosis, but also microatheroma, endothelial dysfunction, and inflammation,” Joundi told 

 in an exclusive interview. “I think that means thrombosis is necessarily part of the pathway of small vein occlusions. Now, whether it’s a terminal part of the pathway after other changes have taken place, that’s something we can’t really answer.”

Joundi’s analysis collected standardized MRI scans from a portion of the patients included in the OCEANIC-STROKE trial. Briefly, OCEANIC-STROKE was a phase 3, double-blind trial enrolling patients with nonlacunar infarcts on imaging, evidence of atherosclerotic plaque at any location in cerebrovascular imaging, or a history of atherosclerosis. These patients were treated with either asundexian or placebo on top of antiplatelet therapy.

A total of 12,327 patients were enrolled in OCEANIC-STROKE – of these, 6162 received asundexian and 6165 received placebo. Ischemic stroke incidence was substantially lower in the treatment arm, while major bleeding incidence was similar across both groups. This indicated asundexian’s comparative efficacy, as well as its minimal impact on bleeding. These data also positioned FXIa inhibition as a promising new approach to stroke prevention.

Joundi and colleagues collected a total of 1126 evaluable MRI scans, identifying 1076 scans with diffusion restricting (DWI+) lesions consistent with acute infarcts. 297 scans showed single small subcortical infarcts, while 565 showed multiple infarcts, 512 showed ≥1 large infarct, and 544 showed ≥1 cortical infarct. Over 19 months of follow-up, the team noted substantial reductions in ischemic stroke in the asundexian arm (8.2% vs 12.1%; cause-specific HR, 0.67; 95% CI, 0.46-0.98), with no significant interaction with infarct pattern.

In regard to secondary stroke prevention, Joundi noted that these data reflect significantly less need to separate out infarct patterns when using FXIa inhibition in patients at risk of recurrent stroke. Joundi believes that asundexian’s consistent benefit across a range of infarct patterns in the substudy can be expanded to small versus large vessel infarcts.

However, Joundi also notes that clinicians still need to be vigilant in preventing secondary stroke through other methods, including vascular risk reduction, hypertension and cholesterol management, and so on. Additionally, although the study displayed a long-term benefit with asundexian, Joundi discusses a need for further investigation at a longer time point to collect MRI scans and confirm the lasting benefit.

“Because asundexian was shown to have a long-term effect in the main trial, with the curves diverging over time, it would be very interesting to design a future trial that actually has MRIs done at much later time points, to see if this long-term reduction in recurrent stroke actually improves markers on the MRI,” Joundi said. “These are some future areas of interest for consideration.”

Editors’ Note: Joundi reports no relevant disclosures.

Joundi R. Effect of Factor XIa Inhibitor Asundexian on Ischemic Stroke Recurrence According to Baseline Infarct Pattern: MRI Substudy of OCEANIC-STROKE Trial. Presented at the World Stroke Congress (WSC) 2026 in Seoul, South Korea. October 21-23, 2026.

Sharma M, Dong Q, Hirano T, et al. Asundexian for Secondary Stroke Prevention. New England Journal of Medicine. 2026;394(15):1467-1479. 

Videos

Raed Joundi, MD, discusses the implications of his substudy of OCEANIC-STROKE and how it could change secondary prevention in ischemic stroke care.

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Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

 news in October 2026 included the first 

 approval of an antisense oligonucleotide for chronic hepatitis B virus (HBV) infection, a unified international definition of acute-on-chronic liver failure (ACLF), and new American College of Gastroenterology (ACG) guidance on preventive care in cirrhosis.

 in Nashville, investigators presented new findings in 

metabolic dysfunction-associated steatotic liver disease (MASLD)

, and cholestatic pruritus. Updates included real-world comparisons of elafibranor and obeticholic acid (OCA), cardiovascular outcomes associated with resmetirom versus semaglutide, and 96-week efruxifermin data in metabolic dysfunction-associated steatohepatitis (MASH). Additional findings addressed ileal bile acid transporter (IBAT) inhibitors in 

HCPLive also examined why declining US alcohol consumption may not immediately translate into fewer cases of alcohol-associated liver disease (ALD).

Here are 8 hepatology headlines from October 2026, spanning regulatory decisions, clinical guidance, research findings, and expert perspectives. For additional meeting coverage, see HCPLive's 

What were the biggest hepatology developments in October 2026?

Major developments included FDA approval of bepirovirsen for chronic hepatitis B, an international consensus definition and grading system for ACLF, and new ACG guidance on preventive care in cirrhosis. ACG 2026 also featured data on treatments for PBC, MASH, MASLD, and cholestatic pruritus.

What is new about the FDA approval of bepirovirsen for hepatitis B?

Bepirovirsen is the first FDA-approved antisense oligonucleotide for chronic HBV infection. In the phase 3 B-Well trials, approximately 1 in 5 treated patients achieved functional cure, defined by sustained HBV DNA suppression and HBsAg loss for at least 24 weeks after stopping all treatment.

What did ACG 2026 reveal about emerging liver disease treatments?

Research presented at ACG 2026 included higher ALP normalization rates with elafibranor versus OCA in a real-world PBC analysis, 96-week antifibrotic findings for efruxifermin in MASH, an association between resmetirom and lower MACE risk versus semaglutide, and reductions in cholestatic pruritus with volixibat.

FDA Approves Bepirovirsen (Hibsago) for Chronic Hepatitis B

On October 20, 2026, the FDA approved GSK's bepirovirsen (Hibsago) for chronic HBV infection, marking the first approval of an antisense oligonucleotide for the disease. Bepirovirsen is indicated for use with nucleos(t)ide analogue therapy in adults without cirrhosis who have received antiviral therapy for at least 6 months, have suppressed HBV DNA, and have hepatitis B surface antigen (HBsAg) levels of 3000 IU/mL or lower.

In the phase 3 B-Well 1 and B-Well 2 trials, functional cure occurred in 20% and 19% of patients receiving bepirovirsen, respectively, compared with no patients receiving placebo. Functional cure was defined as sustained HBV DNA suppression and HBsAg loss for at least 24 weeks after stopping all treatment. The prescribing information includes a boxed warning for serious liver reactions and thrombocytopenia.

Ahead of the approval, Tatyana Kushner, MD, discussed the B-Well findings and the pursuit of functional cure in chronic HBV on 

Global Liver Societies Issue Unified Definition, Grading for Acute-on-Chronic Liver Failure

On October 30, 2026, 5 international liver societies announced a unified definition and grading system for ACLF, published jointly in 4 journals as an 81-statement position paper. The participating organizations were the American Association for the Study of Liver Diseases (AASLD), European Association for the Study of the Liver (EASL), Asian Pacific Association for the Study of the Liver (APASL), Latin American Association for the Study of the Liver (ALEH), and Society on Liver Disease in Africa (SOLDA).

The consensus defines ACLF as liver failure, characterized by bilirubin ≥5 mg/dL and an international normalized ratio (INR) ≥1.5, accompanied by at least 1 extrahepatic organ dysfunction or failure in patients with advanced chronic liver disease. Type A ACLF occurs without prior decompensation, whereas type B occurs in patients with previously decompensated cirrhosis.

The grading system ranges from grade 1, involving liver failure and 1 organ dysfunction, to grade 3, involving liver failure and at least 2 organ failures. The societies developed the framework to address differences among regional definitions that have complicated comparisons across studies and the design of international clinical trials.

ACG Guideline Sets 18 Preventive Care Recommendations for Cirrhosis

, the ACG guideline on preventive care in cirrhosis includes 18 graded recommendations and 6 key concept statements. The guideline was led by Elliot B. Tapper, MD.

Recommendations address prevention of variceal bleeding, hepatocellular carcinoma (HCC) surveillance, vaccination, and modifiable risk factors. They include carvedilol or endoscopic variceal ligation for high-risk varices, HCC surveillance with ultrasound and alpha-fetoprotein every 6 months in eligible treatment candidates, and vaccination against hepatitis A, influenza, SARS-CoV-2, and respiratory syncytial virus (RSV). The guideline also recommends smoking cessation counseling and advises against aspirin solely for HCC prevention.

, Jasmohan Bajaj, MD, MS, discussed the ACG's hepatic encephalopathy (HE) guideline, including the limitations of ammonia testing in diagnosis and the role of rifaximin alongside lactulose.

Elafibranor vs Obeticholic Acid for ALP Normalization in PBC

A propensity-matched TriNetX analysis presented at ACG 2026 found higher rates of alkaline phosphatase (ALP) normalization among patients with PBC receiving elafibranor compared with OCA. Among 444 patients in each treatment group, ALP normalized in 23.4% of those receiving elafibranor and 14.6% receiving OCA, an 8.8-percentage-point difference (P = .0009).

Median follow-up differed between groups, at 207 days for elafibranor and 365 days for OCA, limiting direct comparisons. OCA was withdrawn from the US market in September 2025.

 of 14 patients who transitioned from OCA to elafibranor reported a mean ALP reduction of 33.1% at 6 months, adding to emerging evidence on biochemical response following treatment changes.

Efruxifermin Shows Durable Antifibrotic Response in MASH Through 96 Weeks

At ACG 2026, Arun Sanyal, MD, presented 96-week findings from the phase 2b HARMONY and SYMMETRY trials evaluating efruxifermin, an Fc-FGF21 analog, in patients with MASH and varying degrees of fibrosis.

In HARMONY, which enrolled patients with F2 to F3 fibrosis, 75% of patients receiving efruxifermin 50 mg achieved at least 1-stage fibrosis improvement without worsening of MASH, compared with 24% receiving placebo (P < .001). The analysis was based on patients with an available week 96 biopsy.

In SYMMETRY, which enrolled patients with compensated cirrhosis, fibrosis improvement without MASH worsening occurred in 39% of patients receiving efruxifermin 50 mg and 15% receiving placebo (P < .01). The 28 mg dose did not achieve statistical significance in either trial, and SYMMETRY did not meet its primary end point at week 36.

Resmetirom vs Semaglutide and MACE in Real-World MASLD Analysis

A retrospective, propensity-matched TriNetX analysis presented at ACG 2026 associated resmetirom with a lower risk of major adverse cardiovascular events (MACE) compared with semaglutide in patients with MASLD or MASH and fibrosis.

The analysis included 4253 patients in each treatment group. Resmetirom was associated with lower MACE risk at 1 year (HR, 0.50; 95% CI, 0.32–0.80) and 2 years (HR, 0.61; 95% CI, 0.41–0.89). The composite outcome included myocardial infarction, ischemic stroke, and all-cause mortality.

Because the analysis was observational, the findings demonstrate an association rather than a causal cardiovascular benefit. Randomized cardiovascular outcomes data for resmetirom have not been published.

IBAT Inhibitors Volixibat and Maralixibat Reduce Cholestatic Pruritus

New data presented and reported in October highlighted the potential of IBAT inhibition to reduce cholestatic pruritus across different liver diseases.

In the phase 2b VISTAS trial, presented at ACG 2026 by Mitchell Shiffman, MD, 111 patients with PSC and moderate to severe pruritus received volixibat or placebo. Adult ItchRO scores decreased by 2.72 points with volixibat and 1.08 points with placebo, a between-group difference of −1.64 points (P < .001). Diarrhea occurred in 40.3% of patients receiving volixibat and 8.6% receiving placebo.

Mirum Pharmaceuticals also reported topline results from the phase 3 

, which enrolled 52 patients aged 6 months and older with pruritus associated with rare cholestatic liver diseases. In the pediatric primary analysis, maralixibat reduced worst daily itch severity by 0.98 points compared with placebo (

The EXPAND findings have not yet undergone peer review.

Why Alcohol-Associated Liver Disease May Not Have Peaked, With Brian Lee, MD

Heavy drinking declined nationally between 2022 and 2024, but the trend was different among adults aged 50 to 64, according to an analysis discussed by Brian P. Lee, MD, MAS, of Keck Medicine of USC.

In an interview with HCPLive, Lee reviewed his 

 analysis of 114,352 National Health Interview Survey respondents. Heavy drinking declined more than 8% nationally from 2022 to 2024 but increased more than 36% among adults aged 50 to 64 from 2018 to 2024.

Lee said he expects cirrhosis and liver cancer among adults older than 50 to continue increasing through the end of the decade, reflecting the delayed effects of alcohol exposure on liver disease outcomes.

HCPLive explored these trends in a 2-part ALD feature examining 

where ALD stands after the pandemic spike

why declining alcohol use may not yet be reflected in liver outcomes

October 2026 hepatology news includes FDA approval of bepirovirsen for hepatitis B, new ACLF criteria, ACG cirrhosis guidance, and MASH trial data.

Hepatology

Cholangitis

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8 Hepatology Headlines You Missed in October 2026

 recurrence without increasing major bleeding, irrespective of the baseline infarct pattern based on magnetic resonance imaging (MRI), according to a substudy of the OCEANIC-STROKE trial.

Asundexian Reduces Ischemic Stroke Without Increasing Bleeding Regardless of Infarct Pattern

“OCEANIC-STROKE was a really remarkable finding, with the benefit in stroke reduction not having that increased bleeding typical of antithrombotics,” Joundi told 

 in an exclusive interview. “We did this substudy as part of the OCEANIC trial to better phenotype patients with respect to their baseline imaging, infarct pattern, and other markers to see whether any of that information impacts the effect of the treatment.”

OCEANIC-STROKE was a phase 3 double-blind trial evaluating the efficacy of asundexian in addition to antiplatelet therapy in patients with noncardioembolic ischemic stroke or transient ischemic attack (TIA) at risk of recurrent stroke. Patients were eligible for inclusion if they had a nonlacunar infarct on imaging, a history of atherosclerosis, or evidence of atherosclerotic plaque at any location in cerebrovascular imaging. The primary endpoints were time to first ischemic stroke occurrence and first major bleeding occurrence, both recorded ≤31 months.

A total of 12,327 patients were enrolled in OCEANIC-STROKE, with 6162 randomized to the asundexian arm and 6165 to placebo. Over 19 months of follow-up, ischemic stroke incidence was lower among those receiving asundexian than placebo (6.2% vs 8.4%; cause-specific HR [csHR], 0.74; 95% CI, 0.65-0.84; 

 <.001). Major bleeding incidence was similar in both groups (1.9% and 1.7%, respectively; csHR, 1.1; 95% CI, 0.85-1.44), establishing that bleeding risk was not increased with treatment, unlike standard antiplatelet therapy.

In the present study, Joundi and colleagues enrolled consecutive patients with non-cardioembolic stroke, obtaining standardized MRI scans within 5 days of the index event. Infarct patterns were categorized based on number, location, and size of diffusion restricting (DWI+) lesions. The team calculated csHRs to determine whether asundexian’s effects on recurrent ischemic stroke and major bleeding were contingent on baseline infarct pattern.

A total of 1126 evaluable MRI scans were included in the study, of which 1076 (95.6%) had DWI+ lesions consistent with acute infarcts. Single small subcortical infarcts, defined as ≤15 mm, occurred in 297 patients, multiple infarcts in 565 patients, ≥1 large infarct, defined as >15 mm, in 512 patients, and ≥1 cortical infarct in 544 patients. The team found that asundexian treatment was associated with a reduction in ischemic stroke (8.2% vs 12.1%; csHR, 0.67; 95% CI, 0.46-0.98), with no statistically significant interaction with infarct pattern. Joundi and colleagues also noted that only 2 intracerebral hemorrhages occurred per group, and no significant increase in major bleeding with asundexian was found.

Ultimately, Joundi and colleagues determined that asundexian’s effects had no interaction with infarct patterns. Ischemic stroke was substantially reduced and major bleeding was not increased irrespective of baseline infarct patterns based on MRI scans.

“We had a population in this substudy that was at high risk of bleeding, but the risk for intracranial bleeding was very low, not different between the arms,” Joundi said. “I think the safety signal in the main trial is really bolstered by the MRI substudy in this case.”

Bayer. A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic Stroke or After a High-risk Transient Ischemic Attack, a So-called Mini Stroke (OCEANIC-STROKE). ClinicalTrials.gov Identifier: NCT05686070. Updated November 12, 2025. Accessed November 3, 2026. 

https://clinicaltrials.gov/study/NCT05686070

Raed Joundi, MD, discusses his substudy of the OCEANIC-STROKE trial, demonstrating the safety of Bayer’s investigational FXIa inhibitor across the spectrum of infarct patterns.

KT-621, an oral STAT6 degrader, cut mean EASI by 62.6% after 4 weeks with no treatment-related adverse events in a phase 1b atopic dermatitis study.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Oral STAT6 Degrader KT-621 Reduces EASI by 62.6% in Atopic Dermatitis

Christoph Correll, MD, is a clinical professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell.

Correll discusses functional outcomes from SOLARIS and how to monitor and mitigate weight gain with once-monthly subcutaneous olanzapine.

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Schizophrenia

The HCPLive schizophrenia page is a resource for medical news and expert insights on the mental disorder. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for schizophrenia, and more.

Olanzapine LAI: Function vs Weight Gain, With Christoph Correll, MD

Nephrology in October 2026: FDA approves ravulizumab for IgAN, plus ORIGIN 3, RAINIER, TELIGAN, and ATTACK data from Kidney Week.

Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

FDA News

Chronic Kidney Disease

IgA Nephropathy

The HCPLive Berger disease page is a resource for medical news and expert insights on IgA nephropathy. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in Berger disease, and more.

8 Nephrology Headlines You Missed in October 2026

HCPLive recaps October 2026 dermatology highlights, including data in hidradenitis suppurativa, atopic dermatitis, psoriasis, lupus, and alopecia areata.

8 Dermatology Headlines You Missed in October 2026

pediatric pulmonologist and sleep medicine physician at University Hospitals (UH) Rainbow Babies and Children’s Hospital.

Moshe Prero, MD, says bronchopulmonary dysplasia remains relevant into adulthood and details home safety priorities for children with tracheostomies.

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Prifemilast Achieves PASI 75 in Up to 57% of Patients With Psoriasis

Q&A: Asthma Remission from Year 1 To Year 2 With Depemokimab

Asundexian and the Role of Factor XIa Inhibition in Secondary Stroke Prevention

8 Hepatology Headlines You Missed in October 2026

Asundexian Reduces Ischemic Stroke Without Increasing Bleeding Regardless of Infarct Pattern