The California-based biotech announced this week it had achieved good results in a phase 3 trial of its lead candidate izokibep, a small protein therapy designed to inhibit IL-17A, in patients with the inflammatory skin disorder hidradenitis suppurativa.
At 12 weeks, 33% of patients receiving izokibep had a response across multiple endpoints compared with 21% receiving placebo, a statistically significant difference and a successful primary endpoint of a 75% or greater reduction in total abscess and inflammatory nodule count with no increase in abscess or draining tunnel count relative to baseline.
Despite this, Acelyrin also announced it would be refocusing on its other candidate therapy lonigutamab, an anti-IGF-1R monoclonal antibody for treatment of thyroid eye disease, instead of izokibep. It also announced it would be cutting a third of its staff as part of the reorganization.
“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,” said Mina Kim, CEO of Acelyrin in a press statement.
Emerging from a checkered past
Originally developed by Swedish biotech Affibody, Acelyrin obtained worldwide rights to develop and commercialize izokibep in 2021.
Failure of a phase 2b/3 trial of izokibep, also in hidradenitis suppurativa, caused problems for the company shortly after it launched on the Nasdaq with an unusually large IPO of US$540 million last year. Acelyrin later alleged this failure was due to research errors by a CRO involved in the research.
A subsequent phase 2b/3 trial of izokibep in psoriatic arthritis announced results earlier this year showing it had met its primary endpoint of a reduction in symptoms of more than 50% at 16 weeks. The addition of this week’s successful phase 3 results for hidradenitis suppurativa, suggest the initial confidence of investors in izokibep was justified.
New directions
In spite of the recent success of izokibep, Acelyrin has decided to focus on lonigutamab for treatment of thyroid eye disease, which achieved promising phase 1/2 data in an early stage trial announced in May.
Amgen already has a blockbuster treatment in this space, the antibody treatment teprotumumab (brand name Tepezza), which was approved by the US FDA in 2020. Whether Acelyrin’s candidate can stand up to the competition remains to be seen.
“We remain excited by the opportunity for lonigutamab to address unmet needs of patients with thyroid eye disease. 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,” said Kim. “Combined with a reduction in force, this strategic shift allows us to extend our cash runway to mid-2027 and fully fund both phase 3 trials for lonigutamab.”
