Acelyrin will not work with Fortrea on new clinical trials after identifying errors in a study of its drug izokibep in psoriatic arthritis.
The US biotech shared details in a US SEC filing, stating it had “identified clinical trial execution errors in its ongoing Phase IIb/III trial in psoriatic arthritis involving its CRO and one of the vendors engaged by the CRO.”
Fortrea is the clinical research organization (CRO) named in the filing. The vendor has not been identified.
The study – the "PsA trial" – is designed to test the drug – an IL-17A inhibitor - in four dosing arms: 160mg every week, 160mg every other week, 80mg every four weeks and placebo.
However, according to Acelyrin, while the trial protocol was correct, it “was programmed incorrectly by the vendor, resulting in a sequencing error that went further unidentified through the providers’ testing processes.”
Acelyrin is reviewing the izokibep programme including the PsA study and a separate trial in moderate-to-severe hidradenitis suppurativa that Fortrea also ran.
No new studies
Tyler Marciniak, VP and head of corporate affairs at Acelyrin told Clinical Insider the firm will not work with Fortrea on new studies.
“We will not use this CRO for any new trials that we conduct. Based on the outcome of our ongoing evaluation and the planned audit, we will determine the best path forward for the development of izokibep on behalf of patients, which will include a determination of whether to transition our ongoing trials to a new CRO or complete the trials with this existing CRO.”
He added “As the PsA trial is ongoing, the sequencing error has been corrected – the doses are being administered in the order we originally directed.”
Response
In an email Sue Zaranek, Fortrea VP of corporate communications, told us “A Fortrea customer made concerning statements about errors in clinical trials that Fortrea managed on its behalf. We are taking swift and decisive action to investigate this matter along with a comprehensive audit with the third-party vendor.”
She added that “Fortrea disagrees with certain aspects of its customer's description of the situation and clarifies key points in the statement. We are unaware of any basis for the customer to suggest errors in the conduct of its previous study evaluating the investigational product for the treatment of moderate-to-severe Hidradenitis Suppurativa (HS) and we have no reason to question the results of that study.
“Further, the randomization programming error in the Psoriatic Arthritis (PsA) trial was made by a third-party provider, not Fortrea. Notably, the customer has concluded there is no risk to patient safety resulting from the dose sequencing errors.
“In accordance with our shared responsibility of study oversight under applicable regulations, we are working with the customer to further understand the details and impact. We do not plan to speculate in advance of the completion of those efforts. The investigation of this matter is underway and will be ongoing through the upcoming detailed audit with the third-party vendor to identify the root cause of this error,” Zaranek said.
Unplash/maxchen2k