In a double-blow for Neurocrine Biosciences, the San Diego-based biopharma announced disappointing phase 2 study results from two signal-seeking pipeline programs in epilepsy and major depressive disorder.
First, the investigational selective NaV 1.6 inhibitor, NBI-921352, failed to demonstrate meaningful seizure frequency reduction in the phase 2 dose finding study assessing its safety, efficacy, tolerability and pharmacokinetics as adjunctive therapy in adults with focal onset seizures, a common type of seizure experienced by people with epilepsy.
Neurocrine had paid Xenon Pharmaceuticals $50 million upfront in late 2019 to license the asset along with some other pre-clinical compounds. Now, Neurocrine says no further development with NBI-921352 in focal onset seizures is planned but the company will review the study data to see if an ongoing study in SCN8A-developmental epileptic encephalopathy can be salvaged.
Second, Neurocrine revealed that the investigational drug NBI-1065846, part of a collaboration with Takeda, did not meet its primary endpoint in the phase 2 TERPSIS study evaluating its efficacy compared to placebo in patients with anhedonia, an inability to feel pleasure, in major depressive disorder. According to Neurocrine, no further development with NBI-1065846 is planned at this time.
The asset was part of a June 2020 deal with a potential $1.4 billion price tag that granted an exclusive license to Neurocrine for seven pipeline programs, including three clinical stage assets for schizophrenia, treatment-resistant depression and anhedonia.
All is not lost in the partnership, however. Neurocrine and Takeda will 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).