The Phase II/III Aria Study was unsuccessful in achieving statistical significance on the primary endpoint or any secondary objectives, according to Praxis.
The marketwide decline was exacerbated Monday by Praxis Precision Medicines’ 63% drop following the company’s announcement of unfavorable results from a Phase II/III study of PRAX-114 in major depressive disorder (MDD), along with the firm’s decision to focus on movement disorders and epilepsy.
The Phase II/III Aria Study, which evaluated the effectiveness and safety of PRAX-114 as a monotherapy for MDD, was unsuccessful in achieving statistical significance on the primary endpoint or any secondary objectives, according to Praxis.
Statistical significance is usually taken to mean that a result is not likely due to chance. In the instance that a clinical trial does not achieve statistical significance on its primary endpoint, it is generally considered a failure.
The primary objective of the study was change from baseline in the 17-item Hamilton Depression Rating Scale total score on day 15. While Praxis did not specifically state that it is discontinuing this program, the renewed focus on movement disorders and epilepsy would seem to suggest this.
The Hamilton Depression Rating Scale, in which a clinician will ask the patient a series of questions about their current mood, energy levels, sleep, appetite, etc., is a commonly used tool to evaluate the severity of depression.
The scale ranges from 0 to 50, with higher scores indicating more severe depression. To be considered clinically significant, a change in score of at least four is generally required.
Marcio Souza, president and CEO of Praxis, expressed his surprise and disappointment at the failed study, noting that PRAX-114 was well tolerated but failed to meet the needs of patients.
“Praxis is committed to our mission to help people suffering from CNS disorders and will prioritize our programs in movement disorders and epilepsy moving forward,” Souza said in a statement.
The realignment is expected to extend the company’s cash runway into 2024. Praxis indicated that the restructuring would also result in the loss of jobs, though the company did not disclose a number or percentage.
The failed trial and subsequent change in strategic direction all but eliminate the possibility of Praxis competing in the MDD space with companies like Axsome Therapeutics, which last week published from its pivotal Phase III Gemini trial of AXS-05. The study of AXS-05, an NMDA receptor antagonist, demonstrated rapid, substantial and statistically significant improvement in depressive symptoms and induction of remission.
Going forward, Praxis said its focus will be on other programs, including anticipated results for a Phase IIb study for PRAX-944 in essential tremor and proof of concept for PRAX-562 in epilepsy as well as advancing the preclinical pipeline.
