David Golden, MD, clinical associate professor of medicine at Johns Hopkins University School of Medicine.

David Golden, MD

HCPLive Five at ACAAI 2025

American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting

 in Orlando, leading clinicians from UT Health Houston, the University of Alberta, Johns Hopkins University School of Medicine, and community allergy practices presented pivotal updates in asthma, immunology, dermatology, and anaphylaxis care. This HCPLive Five highlights emerging data across eosinophilic disorders, chronic rhinosinusitis, hereditary angioedema (HAE), anaphylaxis management, and atopic dermatitis, each offering clinicians new insights into rapidly evolving therapeutic landscapes.

Benralizumab Reduces HES Flare in Phase 3 Trial, With Princess Ogbogu, MD

Benralizumab significantly reduced flare events and fatigue in patients with hypereosinophilic syndrome (HES), according to phase 3 NATRON results presented at ACAAI 2025. In an interview with HCPLive, Princess Ogbogu, MD, of the University of Hospitals Rainbow Babies & Children’s Hospital, highlighted the therapy’s impact on time to first flare, annualized flare rates, and hematologic relapse, noting patients on benralizumab did significantly better than those on placebo. Improvements in PROMIS Fatigue scores emerged by week 4. Safety findings aligned with prior benralizumab data, with mostly mild adverse events.

Dupilumab Shows Promise for Allergic Fungal Rhinosinusitis in Phase 3 Trial, With Amber Luong, MD, PhD

Dupilumab demonstrated strong efficacy for allergic fungal rhinosinusitis (AFRS) in the phase 3 LIBERTY AIMS trial, offering a potential new option for this challenging CRSwNP subtype. Amber Luong, MD, PhD, from UT Health Houston, presented data at ACAAI 2025 showing significant improvements in sinus opacification, nasal polyp size, and congestion by weeks 24 and 52, with dupilumab reducing the need for oral steroids or surgery by 92%. The year-long study enrolled 62 rigorously diagnosed patients and met all primary and secondary endpoints. Safety findings aligned with dupilumab’s known profile.

Sebetralstat Shows Promise for On-Demand HAE Treatment in Children, With Adil Adatia, MD

Adil Adatia, MD, from the University of Alberta, presented interim KONFIDENT-KID findings showing that oral sebetralstat safely and rapidly reduced symptoms of hereditary angioedema (HAE) attacks in children aged 2 - 11 years. The oral plasma kallikrein inhibitor, already approved for patients ≥12, was administered within 30 minutes of symptom onset, with a median time to first improvement of four hours. No treatment-emergent adverse events were reported, and pharmacokinetic data aligned with adult studies. Adatia emphasized the promise of a fast-dissolving oral option for young children, noting its potential to replace challenging IV therapies and transform timely, at-home pediatric HAE management.

Sublingual Epinephrine Film Rapidly Works in Children, With David Golden, MD

David Golden, MD, from Johns Hopkins, presented phase 1 data showing that AQST-109 (Anaphylm), a sublingual epinephrine film, rapidly reaches therapeutic levels in children, triggering cardiovascular effects within 2 minutes. In 32 participants aged 7 – 17 years, pharmacokinetics and pharmacodynamics closely mirrored adult findings, with therapeutic plasma levels achieved by 5 - 8 minutes and peak concentrations at 10 minutes. Heart rate and blood pressure rose early, confirming fast onset. Golden emphasized that the needle-free film performed comparably to adult data and may offer an effective alternative to intranasal and injectable epinephrine options for children at risk of severe allergic reactions.

Tapinarof Shows Early, Sustained Benefits in Pediatric Atopic Dermatitis, With Druhan Howell, MD

Druhan Howell, MD, a pediatrics-trained allergist practicing in Mobile, Alabama, highlighted sub-analysis data from the ADORING 1 and 2 trials showing that 1% tapinarof cream delivers early, sustained benefits in children aged 2–17 with atopic dermatitis (AD). Across 654 pediatric patients, including those with asthma, allergic rhinitis, or food allergies, tapinarof improved skin clearance, eczema severity, itch, sleep, and overall symptom burden as early as week 1, with effects maintained through week 8. EASI-75 and vIGA-AD™ response rates were significantly higher than vehicle, regardless of comorbidities. Safety was consistent with prior findings, with no new signals.

Videos

This HCPLive Five features advancements in asthma, immunology, and allergy that were presented at the ACAAI 2025 meeting in Orlando.

Sublingual Epinephrine Film Well Tolerated in Children, With David Golden, MD

2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting

, David Golden, MD, clinical associate professor of medicine at Johns Hopkins University School of Medicine, shared insights with 

 on the safety and potential impact of AQST-109 (Anaphylm), a sublingual epinephrine film recently evaluated in a pediatric phase 1 trial.

The open-label, single-treatment study enrolled 32 children aged 7 to 17 years with a history of allergic reactions and high risk for 

. According to Golden, the treatment demonstrated a favorable safety and tolerability profile consistent with adult data and traditional injectable epinephrine.

Adverse events were frequently observed but aligned with the expected pharmacologic effects of the sublingual formulation. Because the film is administered under the tongue, local reactions such as mild tingling and irritation, or redness were common. These effects were generally minor, resolved quickly without intervention, and did not discourage participants from future use.

Systemic side effects, including temporary shakiness, headache, and increased heart rate, were consistent with the known response to epinephrine. These transient reactions are considered pharmacodynamic markers of drug activity rather than safety concerns.

“If nobody had those side effects, the drug probably wouldn’t be working,” Golden said.

Golden emphasized that, unlike injectable epinephrine, sublingual delivery avoids needle-related pain and fear, which are among the biggest barriers to timely use. While injectables may cause site pain or bruising, sublingual administration mainly produces local oral effects, offering a different but predictable safety profile. According to Golden, research is underway to develop an appropriate sublingual dose for children weighing under 30 kilograms, which could further expand access to fast-acting, easy-to-use epinephrine therapy for pediatric anaphylaxis.

“Epinephrine is not a dangerous drug,” he said. “It may make your heart race, it may make you shaky. That just shows that it's working. Can it raise the blood pressure and heart rate in an elderly person who has heart problems? Yes. But if that person is [experiencing] anaphylaxis, that's way more dangerous than giving them the epinephrine. There's actually no contraindication to giving epinephrine to someone in anaphylaxis, none at all, even if they just had heart surgery yesterday.”

A relevant disclosure for Golden includes Genentech USA, Inc and Phadia US, Inc.

Greenhawt M, Anagnostou A, Christensen S, et al. Phase 1 Evaluation of Sublingual Film: Pharmacokinetics/Pharmacodynamics Safety Tolerability in at Risk Pediatric Patients. Presented at ACAAI 2025 in Orlando, Florida on Saturday, November 8, 2025

At ACAAI 2025, Golden discussed how mild local reactions and expected systemic effects support the sublingual film’s strong safety profile in children.

A recent phase 1 study found that AQST-109 (Anaphylm), a sublingual epinephrine film, rapidly achieves therapeutic levels in children, with effects seen within 2 minutes.

“If we talk about a level of 100 picograms as being the level where it starts to work, it achieves that within 5 to 8 minutes,” David Golden, MD, clinical associate professor of medicine at Johns Hopkins University School of Medicine, told HCPLive during an on-site interview at the 

 in Orlando, Florida. “It actually achieves the highest concentration within 10 minutes, C max. But the important thing here is in the pharmacodynamics, epinephrine starts to work long before it reaches any really high levels in the plasma.”

He added that heart rate and blood pressure are considerably elevated at 2 minutes, suggesting that sublingual epinephrine film begins working in under 2 minutes.

Golden presented the phase 1 data on the pharmacokinetics and pharmodynamics of sublingual epinephrine film in the pediatric population during ACAAI 2025. When HCPLive sat down with Golden, he discussed these findings and how the sublingual film compares to other needle-free options, including the relatively new intranasal epinephrine spray, Neffy.

The open-label, single-treatment, multi-site trial enrolled 32 children aged 7 to 17 years (mean age: 13 years; 20% male, weighing ≥ 30 kilograms (median weight: 47.15 kg), with the goal of “bridging” pediatric pharmacokinetics and pharmacodynamics to adult data. All participants had a history of allergic reactions and were at high risk for 

. The study included a post-treatment follow-up on day 2.

The primary endpoint was the pharmacokinetics following AQST-109 administration, and secondary endpoints included observed effects from 0 to 60 minutes and time to maximum effect for heart rate and blood pressure (systolic and diastolic). Children received a single 12 mg dose of AQST-109 sublingually.

With AQST-109, children experienced elevated systolic blood pressure, diastolic blood pressure, and heart rate. The times to maximum effect were the following: 11 minutes, 8 minutes, and 12 minutes, respectively.

“The pharmacokinetic profile showed that the level of epinephrine in the plasma builds up just as rapidly to just as high a level in children as it does in adults,” Golden said. “In the children, the blood pressure and heart rate were quite comparable to what we've seen in adults…this helps us to know that anaphylm in children should have the same effect, effectiveness, and safety…as what we've shown in adults.”

A relevant disclosure for Golden includes Genentech USA, Inc. and Phadia US, Inc.

Greenhawt M, Anagnostou A, Christensen S, et al. Phase 1 Evaluation of Sublingual Film: Pharmacokinetics/Pharmacodynamics Safety Tolerability in at Risk Pediatric Patients. Presented at ACAAI 2025 in Orlando, Florida, on Saturday, November 8, 2025.

Children achieved therapeutic epinephrine levels within 2 minutes on AQST-109 (Anaphylm), showing an early cardiovascular response similar to adults.

HCPLive Five – Allergy Updates at AAAAI 2025

 2025 Academy of Allergy, Asthma, & Immunology (AAAAI) 

annual meeting in San Diego to connect with colleagues, explore late-breaking data, and attend hundreds of sessions.

 Allergy Team reported live from San Diego, conducting dozens of interviews and covering late-breaking research. In this iteration of the HCPLive Five, the team highlighted standout video interviews, covering topics such as insect allergy testing, chronic rhinosinusitis, omalizumab for food allergies, oral immunotherapy with autoclaved peanuts, and the WAYPOINT phase 3 trial assessing tezepelumab for nasal polyp management.

When to Test for Insect Sting Allergies, with David Golden, MD

David Golden, MD, from Johns Hopkins University, discussed the pitfalls of over-testing for insect sting allergies. He emphasized that a positive test does not confirm an allergy, as many people with positive results experience no reaction to stings.

Testing should be reserved for patients with anaphylactic reactions, as unnecessary testing can lead to undue worry and even disqualify individuals from opportunities like military service. Unlike peanut allergies, insect allergy tests do not predict reaction severity, making it crucial for clinicians to avoid misinterpreting strong test results as indicators of severe allergy risk.

When an Allergist Should Refer Endoscopic Sinus Surgery for Chronic Rhinosinusitis, with Kent Lam, MD

Kent Lam, MD, from Eastern Virginia Medical School at Old Dominion University, discussed when allergists should refer patients with chronic rhinosinusitis for endoscopic sinus surgery; surgery is recommended when symptoms persist despite treatment with topical steroids, saline irrigation, or antibiotics.

The procedure aims to improve sinus drainage and ventilation rather than remove tissue. Lam emphasized setting patient expectations regarding risks such as bleeding, scarring, and symptom persistence.

Omalizumab Performs Better Than Oral Immunotherapy for Food Allergy, with Robert Wood, MD

Robert Wood, MD, from Johns Hopkins Medicine, discussed the OUtMATCH trial comparing omalizumab and oral immunotherapy (OIT) for food allergies. The study found omalizumab superior in the intent-to-treat analysis (36% vs 19%;

 = .031), but per-protocol analysis—excluding dropouts—showed similar effectiveness (

OIT had a high dropout rate due to side effects, while omalizumab was well tolerated. Wood emphasized the need for individualized treatment, as OIT may offer long-term immune changes, but omalizumab provides a safer alternative with fewer side effects.

Patients Tolerate Oral Immunotherapy Better with Autoclaved vs Blanched Peanuts, with Casey Cohen, PhD

A study found that peanut-allergic patients tolerated oral immunotherapy better with autoclaved peanuts than with blanched peanuts. Casey Cohen, PhD, from McGill University, explained that autoclaving—using high temperature and pressure—reduces peanut-specific immunoglobulin binding, resulting in fewer severe reactions.

In a double-blind trial of 10 participants, the median tolerated dose was significantly higher for autoclaved peanuts (300 mg vs. 9 mg). No participants required epinephrine for autoclaved peanuts, whereas all were for blanched peanuts.

Tezepelumab Lowers Nasal Polyp Severity in CRSwNP During Phase 3 WAYPOINT, with Joseph Han, MD

The phase 3 WAYPOINT trial demonstrated that tezepelumab significantly reduced nasal polyp severity in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP), lowering the need for surgery by 92%. Tezepelumab significantly improved nasal congestion, sense of smell, and overall symptom scores at 52 weeks.

Investigator Joseph Han, MD, from Eastern Virginia Medical School, highlighted the near elimination of surgery in the treatment group. These findings support tezepelumab as a promising treatment option for CRSwNP, reducing reliance on systemic steroids and surgical intervention.

GlaxoSmithKline, Regeneron Pharmaceuticals, and AstraZeneca Pharmaceuticals for Lam, Genentech USA for Wood, none for Cohen, and GlaxoSmithKline, Genzyme Corporation, Regeneron Healthcare Solutions, Medtronic, Merck Sharp & Dohme, Optinose, AstraZeneca Pharmaceuticals, Aerin Medical, and PFIZER for Han.

Counting down the most impactful news at major medical meetings, it’s the HCPLive Five! This episode focuses on 5 key allergy updates from the 2025 American Academy of Allergy, Asthma, and Immunology (AAAAI) annual meeting.


David Golden, MD

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