Phase 2 Proof-of-Concept Study of NBI-921352 in Patients with Focal Onset Seizures Failed to Demonstrate Meaningful Reduction in Seizure Frequency

Phase 2 Proof-of-Concept Study of NBI-1065846 in Patients with Anhedonia in Major Depressive Disorder Failed to Meet its Primary Endpoint

SAN DIEGO, Nov. 9, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX), a leading neuroscience-focused biopharmaceutical company, today announced Phase 2 study results from two signal-seeking pipeline programs in focal onset seizures and anhedonia.

"We are disappointed with the outcome of these studies, but remain fully committed to finding new treatment options for patients living with serious neurological and neuropsychiatric disorders, including epilepsy and major depressive disorder," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences, Inc. "Additionally, we are grateful to the study participants and everyone involved in these studies."

Epilepsy Update: The investigational selective NaV 1.6 inhibitor, NBI-921352, licensed from Xenon Pharmaceuticals, Inc. (Xenon), failed to demonstrate meaningful seizure frequency reduction in the Phase 2 dose finding study assessing the safety, efficacy, tolerability and pharmacokinetics as adjunctive therapy in adults with focal onset seizures. No further development with NBI-921352 in Focal Onset Seizure (FOS) is planned at this time. Neurocrine is reviewing the data from the FOS study to understand any potential implication for its ongoing study in SCN8A-developmental epileptic encephalopathy and will provide an update once this review is complete. The company continues to advance a pre-clinical dual NaV1.2/1.6 inhibitor as part of the Xenon collaboration.

Psychiatry Update: The investigational NBI-1065846, as part of the collaboration with Takeda Pharmaceutical Company Limited (Takeda), did not meet its primary endpoint in the Phase 2 TERPSIS™ study evaluating its efficacy compared to placebo in patients with anhedonia in major depressive disorder. No further development with NBI-1065846 is planned at this time. Neurocrine and Takeda continue to collaborate on several programs in clinical development including NBI-1065845 for the treatment of inadequate response to treatment in major depressive disorder (Phase 2), luvadaxistat for the treatment of cognitive impairment associated with schizophrenia (Phase 2), and NBI-1070770 for the treatment of major depressive disorder (Phase 1).