Despite a positive phase 3 trial for its lead candidate, izokibep, California biotech Acelyrin revealed plans to cease investments in the IL-17A inhibitor, instead focusing on its thyroid eye disease (TED) candidate.
The "refocused pipeline strategy" will use the company's existing cash resources to prioritize lonigutamab, a mid-stage subcutaneous anti-IGF-1R treatment. Acelyrin is currently testing different doses and dose regimens with a goal of establishing a minimum effective dose and selecting the dose regimen for the phase 3 program, which the biotech anticipates starting in the first quarter of 2025.
The strategic shift will also come with a 33% workforce reduction, which the company anticipates will extend its cash runway to mid-2027 and fully fund both phase 3 trials for lonigutamab.
In the same press release, Acelyrin revealed that its phase 3 trial of izokibep in chronic skin disease, hidradenitis suppurativa (HS), had achieved its primary endpoint of HiSCR75 (75% reduction in total abscess and inflammatory nodules) at 12 weeks. While the company plans to complete the drug's ongoing trials in HS and active psoriatic arthritis, going forward, it will suspend new investment in the indications.
“While today’s positive HS data and previously announced psoriatic arthritis (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,” said Mina Kim, Acelyrin CEO.
Acelyrin was one of the biggest biotech IPOs of 2023, raising $540 million in May 2023.