By Michel Dabaie
Shares of Praxis Precision Medicines Inc. fell 63% to $3.22 premarket on Monday after the company announced negative results for a Phase 2/3 study of PRAX-114 in major depressive disorder. and that the company would now focus on movement disorders and epilepsy.
The Phase 2/3 Aria study evaluating the efficacy and safety of PRAX-114 for the monotherapy treatment of major depressive disorder did not reach statistical significance on the primary endpoint or endpoints secondary, Praxis said.
The primary objective of the study was the change from baseline in the 17-item Hamilton Depression Rating Scale total score at day 15.
Praxis plans to prioritize its movement disorder and epilepsy programs in the future, he said. The strategic realignment would result in a reduction in future workforce and operating expenses, the company said. Following the realignment, the company’s cash trail would now extend to 2024.
The strategic alignment would focus on delivering Phase 2b results for PRAX-944 in essential tremor and proof-of-concept for PRAX-562 in epilepsy and advancing the preclinical pipeline, Praxis said.
Praxis is completing screening in the Phase 2 Acapella study of PRAX-114 in major depressive disorder at doses up to 60 mg, and expects to read results from approximately 100 patients in the third quarter, it said. it said in a U.S. Securities and Exchange Commission filing. . The company is also halting enrollment in its Phase 2 study of PRAX-114 in post-traumatic stress disorder and plans to review the safety data once available, she said.
The company is discontinuing its Phase 2 crossover study to assess the safety, pharmacokinetics and efficacy of daytime administration of PRAX-114 for the treatment of essential tremor.
Write to Michael Dabaie at [email protected]