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In this Q&A, Soong discusses phase 2 results on povorcitinib, a JAK1 inhibitor that provides rapid relief from chronic spontaneous urticaria symptoms.
At the 2025 American College of Allergy, Asthma, & Immunology (ACAAI) Annual Scientific Meeting in Orlando, Weilly Soong, MD, from AllerVie Health – Homewood in Birmingham, AL, presented phase 2 data showing povorcitinib provides rapid Improvement in hives and itch in patients with chronic spontaneous urticaria (CSU). Povorcitinib, a JAK1 inhibitor that blocks IL-4, IL-13, IL-31, and IL-6, improved itch and hives within 3 days and had a favorable safety profile.
As a part of HCPLive’s on-site coverage of the meeting, HCPLive sat down with Soong to discuss the significance of these findings and what they mean for clinicians. In this Q&A, Soong shares when patients began experiencing meaningful symptom improvements, why the need for new effective therapies in CSU is so pressing, and the future direction of povorcitinib research.
HCPLive: Can you summarize the key findings from this study on povorcitinib for chronic spontaneous urticaria?
Soong: In the 75 mg dose of povorcitinib, we saw an improvement of 22 percent change [from baseline in the] UASa7, which was statistically significant. It had a very rapid itch [improvement] within the first 2 to 3 days.
HCPLive: How quickly did patients begin to experience meaningful improvements in hives and itch, and how do these response times compare to current treatment options?
Soong: Overall, [the] urticaria score was low by day 3. Compared to [other] biologics like omalizumab and dupilumab, it works a lot faster. But [compared] to a BTK, it's roughly the same. One of the BTK inhibitors is remibrutinib. However, there [have] not been any head-to-head studies amongst them, so you can't quite make that comparison.
HCPLive: Why is the need for new effective therapies in CSU so pressing, particularly for patients refractory to antihistamines or biologics?
Soong: Currently, there's a very much huge unmet need in the CSU area. There are a lot of patients [who] do not want to [start] a biological therapy because maybe [they] just started having CSU.
A lot of people think that CSU is triggered by external triggers, and so they're trying to find something in their environment that might be causing their urticaria. Some people think it may be due to foods, detergents, soaps, [or] activities. And so, they often are very miserable with their urticaria and very resistant to doing something like a biologic. This is the reason why there's a huge unmet need.
HCPLive: Povorcitinib is an oral selective inhibitor. What role does this pathway play in the pathophysiology of CSU, and how might targeting it differ from current biologic therapies?
Soong: We know that chronic spontaneous urticaria is a disorder of mast cells, and the mast cells are unpredictably firing and releasing histamine and causing hives. We know that there are autoantibodies and autoallergenic antibodies that turn on these cells. What the JAK inhibitor does is that it helps block the production of these cells. It also works on some of the itch pathways that are seen in chronic urticaria.
HCPLive: Can you highlight any other efficacy findings?
Soong: The proportion of patients that reached a hive score of 0 and an itch score of 0 at 12 weeks was 50 percent and 53 percent, respectively.
HCPLive: What did the trial reveal about povorcitinib’s safety and tolerability?
Soong: We tested 3 doses of [povorcitinib]. The 15 mg, the 45 mg, and the 75 mg were all well-tolerated with no safety signals observed. The most common effects were acne, headaches, and nasopharyngitis. There were 3 severe adverse events that were only in the placebo arm, and then 2 patients receiving the 45 mg discontinued due to tinnitus and subcutaneous abscess, while 2 patients receiving povorcitinib at 75 mg discontinued due to an increase in serum ferritin and acne.
HCPLive: What's next for povorcitinib research moving forward?
Soong: What this study showed is that…JAK inhibitors are a potential treatment therapy for chronic spontaneous urticaria. Currently, the program for povorcitinib with chronic spontaneous urticaria is on hold due to priorities of the company.
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