CRO disputes Acelyrin’s implication of trial misconduct

Dive Brief:

• A contract research organization working for biotechnology company Acelyrin is disputing suggestions that it may be responsible for the failure of a high-profile study released in September.
• On Monday, Acelyrin said it began implementing extra quality control measures for research after the experimental drug izokibep missed its goal in a Phase 2b/3 trial amid “certain confounding factors.” In the process, Acelyrin said it discovered a sequencing error in a separate trial of the drug run by the same CRO, called Fortrea, and now plans an audit of all of the CRO’s work.
• Fortrea is standing behind its procedures, disputing Acelyrin’s implication and subsequent media reports that linked the problem in one trial to the failure of the other. In a filing Wednesday, Fortrea also said Acelyrin had not given an accurate description of the situation in the second trial, which involved an error by an undisclosed third-party vendor.

Dive Insight:

The study failure in September was notable news, as it came just months after Acelyrin debuted on the market with the largest biotech initial public offering in more than two years. At the time, Acelyrin said the trial’s results showed signs its drug was effective at treating a skin condition called hidradenitis suppurativa. But the company flagged odd findings like an unusually high response rate in the placebo group.

Fortrea is running a separate study of the medicine in patients with psoriatic arthritis, and that’s where the sequencing error was identified. According to Acelyrin, a third-party vendor programmed the dosing protocol incorrectly, resulting in some patients getting placebo and active treatment in a random order rather than a prespecified alternating pattern.

Acelyrin said the error did not put any patients in danger, because no participants got more of the treatment than they should have. But the sequencing error may affect the trial’s final results, and Acelyrin said Monday it’s still reviewing the implications.

In the meantime, Acelyrin is hiring a third-party auditor to look at all the trials being run for the company by Fortrea. Acelyrin said it won’t use Fortrea for any new studies and may consider transitioning ongoing research to a new CRO.

For its part, Fortrea said it will continue to work with Acelyrin and “help it navigate the best path forward.” The company, spun out of Labcorp earlier this year, also stressed that it has successfully run thousands of clinical trials for more than 30 years, “all while upholding the highest standards of integrity for all our customers.”

The back-and-forth between Acelyrin and Fortrea marks the second high-profile CRO dispute this year. In February, Pfizer and Valneva removed about half of the patients from a large Phase 3 trial of an experimental Lyme disease vaccine because of what they called standard violations. The clinical trial contractor, Care Access, later said a regulatory inspection found no evidence of misconduct.