Late-Breaking Data on Bempikibart for Severe Alopecia Areata, with Brett King, MD, PhD

At the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, the HCPLive editorial team spoke with Brett King, MD, PhD—associate professor of dermatology at the Yale University School of Medicine Department of Dermatology—about his team’s late-breaking data on bempikibart for those with severe alopecia areata.1

The findings from the SIGNAL-AA phase 2a study on bempikibart, a drug formerly known as ADX-914, highlight the medication’s efficacy among patients in terms of Severity of Alopecia Tool (SALT) scores and other related results. Among participants who responded that finished the treatment period and demonstrated a SALT response, all were shown to have achieved maintenance of response or additional regrowth of hair during their post-treatment timeframe.

“Yeah, so the study is of an antibody called ADX-914, or bempikibart, and this is an anti-IL-7Rα antibody that ultimately blocks or mediates signaling of IL-7 and TSLP to cytokines that may be very important in the pathogenesis of alopecia areata,” King explained. “And in this randomized, double blind placebo placebo-controlled clinical trial of patients with severe alopecia areata, that is a SALT score 50 to 100, we saw some provocative results.”

King was asked to highlight some of the most notable findings among patients with severe alopecia areata treated with bempikibart.

“I think what's really fun about this clinical trial and its results is not so much what we saw over 24 weeks, which was the time period during which the primary endpoint was measured,” King said. “The primary endpoint being a SALT score less than or equal to 20 is very similar to other clinical trials in patients with severe alopecia areata, but it is the results in follow-up over the next 12 to 24 weeks. What we saw was a signal for efficacy which is provocative.”

King noted that this was because the drug was no longer being dosed, adding that the notion that at longer periods without dosing, to see efficacy signals is unlike most of what investigators have seen to date in clinical trials of JAK inhibitors, for example.

“Wiith JAK inhibitors, typically, when you withdraw a drug over a period of 12 to 24 weeks, you see loss of efficacy beginning really around week 4 or 8,” King said. “So it’s a really interesting, brand new molecule and brand new mechanism of action in alopecia areata. And these are really interesting results which are different than what we've seen to date with other medicines.”

According to King, data collection is ongoing and the open-label extension is planned for around the first half of 2025.

To learn more about bempikibart for alopecia areata, view the full interview posted above. For more late-breakers from AAD 2025, view our latest coverage.

The quotes contained in this video summary were edited for clarity. King has reported personal fees from Eli Lilly, Sun, and Pfizer and his spouse has served as a consultant, speaker, and advisory board member for Pfizer, Eli Lilly, and Sun.

References

1. King B, et al. Initial Results From The SIGNAL-AA Study: Randomized Placebo Controlled Phase 2a Trial of a Bempikibart. Late-breaking data presented at the 2025 American Acamdey of Dermatology Annual Meeting. March 8, 2025.