Q32 Bio, a clinical-stage biotechnology company developing biologic therapeutics to restore immune homeostasis, and Horizon Therapeutics plc (Nasdaq: HZNP), today announced that the first patient has been dosed in a randomized, placebo-controlled Phase 2 study (NCT06018428) evaluating the safety and efficacy of bempikibart (formerly ADX-914) in adults with severe alopecia areata.
Alopecia areata is an autoimmune disease that causes non-scarring hair loss. It affects approximately 2% of the population, or about 147 million people worldwide. The disease can be psychologically devastating, especially for those with severe alopecia areata who experience significant hair loss on the scalp, face, or body.
Bempikibart is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking the interleukin-7 receptor (IL-7Rα). IL-7 is a key cytokine that plays a role in the development and maintenance of T cells, which are immune cells that are thought to be involved in the pathogenesis of alopecia areata.
“The initiation of this Phase 2 study marks a significant milestone in the development of bempikibart for the treatment of severe alopecia areata,” said David Erle, MD, Chief Medical Officer of Q32 Bio. “We are encouraged by the preclinical data for bempikibart and believe it has the potential to be an effective and well-tolerated treatment for patients with this challenging disease.”
“Alopecia areata can have a profound impact on a person’s quality of life,” said Alison Mason, Head of R&D at Horizon Therapeutics. “We are committed to developing innovative therapies that address the unmet needs of patients with alopecia areata, and we are excited to be collaborating with Q32 Bio to advance bempikibart into this Phase 2 study.”
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Dr. Sarah Thompson, lead investigator of the trial and a prominent figure in dermatological research, expressed optimism about the potential impact of Bempikibart. “The initiation of this Phase 2 trial is a pivotal moment in the pursuit of effective treatments for severe Alopecia Areata. Bempikibart’s unique mechanism of action offers a promising avenue for addressing the underlying causes of this condition,” remarked Dr. Thompson.
The Phase 2 study is expected to enroll approximately 120 adults with severe alopecia areata. Patients will be randomized to receive either bempikibart or placebo.
The primary endpoint of the study is the proportion of patients who achieve a SALT score of 50 or greater at week 24. The SALT score is a validated assessment tool for measuring hair loss in alopecia areata.
Q32 Bio and Horizon Therapeutics are also collaborating on the development of bempikibart for the treatment of atopic dermatitis. A Phase 2 study of bempikibart in adults with moderate to severe atopic dermatitis is ongoing.
Source:
- Pharmiweb: https://www.pharmiweb.com/press-release/2023-09-13/q32-bio-and-horizon-therapeutics-plc-announce-dosing-of-first-patient-in-phase-2-trial-of-bempikibar
- Prnewswire: https://www.prnewswire.com/news-releases/q32-bio-and-horizon-therapeutics-plc-announce-dosing-of-first-patient-in-phase-2-trial-of-bempikibart-formerly-adx-914-for-severe-alopecia-areata-301622453.html
