BioCryst suffers Friday morning after reporting it would suspend enrollment in three trials for its lead pipeline program.
In a succinct statement released just before the market opened, the Durham, NC-based biotech company said it had detected elevated serum creatinine levels in some patients and would stop recruiting while it investigates. Elevated creatine levels can be a sign of kidney dysfunction.
The patients were taking the experimental drug BCX9930, an oral factor D inhibitor being studied in three clinical trials.
After Friday’s opening bell, shares of BioCryst $BCRX fell more than 30% to $11.92.
Two of the biotech’s clinical trials evaluated the investigational drug in paroxysmal nocturnal hemoglobinuria (PNH), one in an open-label setting versus an active comparator and one controlled versus placebo. Both were evaluated as monotherapy. BioCryst’s plan was to study BCX9930 in a variety of complement-mediated diseases.
According to clinicaltrials.gov websites, BioCryst had expected to enroll about 140 patients between the two trials, and it’s not immediately clear how many were taking the drug as of Friday’s update. A company spokesman declined to comment, saying BioCryst was not releasing details about the studies.
The hiatus marks a setback for the biotech’s pipeline, just over a year after it received its first FDA approval for Orladeyo, a daily pill designed to prevent painful episodes in patients with the rare disease hereditary angioedema (HAE). BioCryst acted quickly to capitalize on the approval, signing a $250 million deal with Royalty Pharma three days after the green light.
Late last year, the biotech also moved to raise new money, raising another $350 million from royalties and new investors. Some of the money was planned to bring BCX9930 to its NDA and build additional clinical trials, BioCryst said at the time.
This article has been updated to include BioCryst’s response to a request for comment from Endpoints News.