Acelyrin reports positive phase 3 results for izokibep in hidradenitis suppurativa

Acelyrin recently announced encouraging results from a phase 3 study of its IL-17A inhibitor, izokibep, in treating hidradenitis suppurativa (HS). Despite the positive findings, the company has decided not to proceed with developing izokibep for this specific condition.

Hidradenitis suppurativa is a chronic inflammatory skin disease that affects approximately 1% of the population in most studied countries. The condition is characterized by painful nodules and abscesses on the skin.

In the phase 3 clinical trial, izokibep showed statistically significant improvements in several efficacy measures at the 12-week mark. Specifically, 33% of patients receiving a weekly dose of izokibep 160mg achieved at least a 75% reduction in their total abscess and inflammatory nodule count (HiSCR75). This was notably higher compared to 21% of patients who were given a placebo. Furthermore, 25% and 22% of patients treated with izokibep reached HiSCR90 and HiSCR100, respectively, in contrast to 9% and 8% in the placebo group.

These findings were announced shortly after izokibep also yielded promising results in a phase 2b/3 study for psoriatic arthritis (PsA), another chronic inflammatory disease characterized by joint pain, stiffness, and swelling. Acelyrin has committed to completing the ongoing trials for both HS and PsA but will halt new investments in these indications. Additionally, a phase 2b/3 trial of izokibep in uveitis will continue until its primary endpoint is reached, with top-line data expected later this year.

Mina Kim, the CEO of Acelyrin, explained the decision to halt further investment in izokibep for HS and PsA. She stated, "While the positive HS data and previously announced PsA data support a path to approval for izokibep, we have determined that a program of this breadth and size is best brought to market by a larger organization with the resources and existing footprint in these indications."

Moving forward, Acelyrin will shift its focus to the development of lonigutamab, an anti-IGF-1R monoclonal antibody currently being evaluated for treating thyroid eye disease (TED). A phase 2 dose-ranging study for this candidate is already in progress, and the company aims to initiate a phase 3 trial early next year.

Kim expressed optimism about lonigutamab’s potential, stating, "We remain excited by the opportunity for lonigutamab to address the unmet needs of patients with TED. Consistent with our commitment to disciplined capital allocation, we have decided to focus our efforts toward rapidly advancing lonigutamab through late-stage development with our existing cash resources."

In summary, while Acelyrin's izokibep has shown promising results for HS and PsA, the company will not continue developing the drug for these conditions, opting instead to concentrate resources on lonigutamab for TED.