The FDA has thrown a minor wrench in Cortexyme’s unorthodox plan to treat Alzheimer’s.
On Monday, the Bay Area biotech announced that the agency had put one of the studies in their pivotal program on hold after the company reported that patients experienced liver problems while taking their lead drug. The issues were reversible and had no known long-term effects, the company said.
The hold will not affect the Phase II/III, blinded, randomized controlled study they hope to read out towards the end of this year. Instead, the agency has decided to end, for the time being, an open-label extension study that had been measuring their molecule’s long-term effects on patients who already completed the initial 48-week study. No new patients will be enrolled and patients currently in the trial will be discontinued.