Acelyrin has decided to shake up its pipeline; while the company touted positive Phase III data for izokibep in hidradenitis suppurativa (HS), it has also shared its plans to stop further new investment into the development of the therapy.
The US-based company has instead decided to focus its resources on developing its monoclonal antibody, lonigutamab, for treating thyroid eye disease. Acelyrin also plans to “forego the originally planned Phase IIb/III trial design and move directly into a Phase III programme”.
Go deeper with GlobalData
The company plans to hold an end-of-Phase IIa meeting with the US Food and Drug Administration (FDA) by the end of the year, with plans to start the Phase III trial in Q1 2025.
Along with pipeline shuffling, Acelyrin plans to reduce its workforce by a third. It has also stopped the development of an early monoclonal antibody, SLRN-517. The cash-saving measures are expected to extend the company’s cash runway and reported cash reserves of $635.2m as of 30 June 2024 into mid-2027. The company added that it has enough cash reserves to fund the ongoing Phase II trials and two registrational Phase III trials for lonigutamab in thyroid eye disease.
As per the latest data, the Phase III trial (NCT05905783) evaluating izokibep in HS met its primary endpoint with 33% of the participants in the therapy group achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at 12 weeks, compared to 21% in the placebo group.
Despite the current success, izokibep, an interleukin-17A (IL-17A) inhibitor, has had a tumultuous development.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataIn September 2023, a Phase IIb HS trial (NCT05355805) failed to meet the primary endpoint. The results have had a devasting effect on the company’s value. Its stock closed at $4.76 on 13 August a far cry from its high trading price of $27.9 in September 2023.
Acelyrin later accused its contract research organisation (CRO) partner Fortea of allegedly mishandling a trial evaluating izokibep in psoriatic arthritis, which prompted an audit of the entire izokibep programme. The Phase IIb/III psoriatic arthritis trial (NCT05623345) ultimately met its primary endpoint. The company plans to complete the ongoing Phase III and Phase IIb/III trials in HS and psoriatic arthritis, respectively. The company stated that while it has cash reserves to finance the ongoing trials, no new investment will be made in these indications.
The company is also evaluating izokibep as a treatment for uveitis in a Phase IIb/III trial (NCT05384249). The study is expected to “continue through its primary endpoint”, with topline data expected in Q4 this year. Acelyrin hinted at plans to license out izokibep development, with the company’s CEO Mina Kim stating: “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 programme of this breadth and size is best brought to market by a larger organisation with the resources and existing footprint in these indications.”
