Neurocrine hit with two study fails on Takeda, Xenon projects
Phase 2Phase 3Clinical ResultPhase 1
Neurocrine Biosciences announced Friday that two drug candidates separately partnered with Takeda and Xenon Pharmaceuticals missed the mark in a pair of Phase II studies. "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 (MDD)," stated Eiry Roberts, chief medical officer at Neurocrine.
According to the company, a dose-finding study of the selective NaV 1.6 inhibitor NBI-921352 failed to meaningfully reduce seizure frequency when used as adjunctive therapy in adults with focal onset seizures (FOS), so it is scrapping the programme on which it was collaborating with Xenon. Neurocrine said it will review data from the FOS trial to determine any potential implication for its ongoing study in SCN8A-developmental epileptic encephalopathySCN8A-developmental epileptic encephalopathy. It continues to advance a preclinical dual NaV1.2/1.6 inhibitor as part of its 2019 epilepsy collaboration with Xenon.
Meanwhile, a second compound dubbed NBI-1065846 did not meet its primary endpoint in the placebo-controlled TERPSIS study involving MDD patients with anhedonia. The GPR139 agonist, also known as TAK-041, is partnered with Takeda as part of deal potentially worth close to $1.9 billion. There are no plans to continue developing NBI-1065846. However, Neurocrine said the companies continue to collaborate on several programmes, including NBI-1065845 for the treatment of inadequate response to MDD treatment, as well as luvadaxistat for cognitive impairment associated with schizophrenia. Both are in Phase II, while another asset, NBI-1070770, is in Phase I testing for MDD.
Failures could 'stunt momentum'
The trial results "remind us of the riskiness of Neurocrine's broader pipeline," commented BMO Capital Markets analyst Evan Seigerman, noting that the failures are "likely to stunt momentum."
Meanwhile analysts at Morgan Stanley said the results for NBI-1065846 were "not a surprise to us or many investors, as anhedonia in MDD has been a challenging indication." However, they said they had been "optimistic that NBI-921352 would read out positively as there was biologic
rationale - selectivity to Nav1.6 - to believe it could work." Still, while the analysts expect Neurocrine shares will face headline risk in the near term, they think "it should be limited."
Neurocrine recently reported two positive Phase III readouts for its oral CRF1 antagonist crinecerfont in congenital adrenal hyperplasia, including in adult and paediatric patients.
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