Acelyrin Reassesses Flagship Immunology Asset Izokibep Following Multiple Clinical Trial Setbacks

Clinical Trial Failure:
Acelyrin's lead asset, izokibep, an IL-17A inhibitor, failed to meet the primary endpoint in a Phase 2b/3 trial for moderate to severe hidradenitis suppurativa, causing a significant drop in the company's stock price12.

IPO and Financial Impact:
The failure occurred just months after Acelyrin raised $540 million in a rare biotech IPO, leading to a 58% decline in premarket trading1.

Investigation into Trial Errors:
Acelyrin later identified a programming error by a contract research organization (CRO), Fortrea, in a separate trial for psoriatic arthritis, which may have impacted the results. The company is conducting a broader review and independent audit3.

Continued Development:
Despite the setbacks, Acelyrin remains committed to developing izokibep, citing potential in other indications and ongoing trials, including a Phase 2b/3 trial in psoriatic arthritis with results expected in the first quarter of 202413.

Comparative Context:
The failure echoes similar setbacks in the biotech industry, such as Alto Neuroscience's depression treatment failing a mid-stage trial, highlighting the challenges in drug development4.

Sources:

1. https://www.fiercebiotech.com/biotech/acelyrin-fails-late-phase-clinical-trial-months-after-540m-ipo-sending-stock-hurtling

2. https://endpts.com/acelyrins-il-17-inhibitor-fails-to-hit-primary-endpoint-in-key-study-after-splashy-ipo/

3. https://www.fiercebiotech.com/biotech/acelyrin-blames-cro-error-shocking-phase-3-failure-sent-shiver-through-biotech-ipo-market

4. https://www.biospace.com/drug-development/alto-depression-therapy-fails-mid-stage-trial-9-months-after-ipo