Arden & Pryce trial revisions shake confidence in a new class of fibrosis drugs
The company confirmed a small number of liver-related safety events, including one death, though investigators have not determined whether the drug was responsible.
By Lena FischerPublished · 1 min read
Arden & Pryce has tightened the entry criteria for two late-stage studies of its experimental lung fibrosis drug after a "limited number" of participants developed signs of liver injury, a spokesperson confirmed Thursday.
One patient died. An independent monitoring committee reviewed the cases and recommended the trials continue with additional liver testing and the exclusion of patients with certain pre-existing conditions.
The changes came to light through an update to a public trial registry rather than a company announcement, which unsettled investors. Shares fell 6%, and two smaller developers working on drugs with the same mechanism dropped by more.
Until the cases are unblinded, nobody outside the monitoring committee knows whether these patients were even on the drug.
Results from the first study are expected in the second half of next year.
