Takeda-Partnered Neurocrine Drug Shows Promise in Phase II Depression Trial

Neurocrine Biosciences announced promising data from its Phase II SAVITRI trial, indicating that their experimental drug, NBI-1065845, developed in collaboration with Takeda Pharmaceuticals, has the potential to significantly alleviate depression in adults with major depressive disorder (MDD).

The trial included 183 patients who had previously seen inadequate responses to existing antidepressant treatments. Initial results revealed that a once-daily oral dosage of NBI-1065845 reduced the Montgomery Åsberg Depression Rating Scale (MADRS) score by 4.3 points more than the placebo at the 28-day mark, achieving statistical significance with a p-value of 0.0159. MADRS is a widely used tool for measuring the severity of depressive episodes. By day 58, the drug's impact increased, showing a 7.5-point reduction compared to the placebo.

A secondary dose of NBI-1065845 also showed improvements over placebo. However, these effects did not reach statistical significance on both day 28 and day 56 measurements.

In terms of safety, NBI-1065845 was generally well tolerated. The most frequently reported side effect was a headache, and the overall adverse event profile was similar to that of the placebo. The trial noted no deaths or severe adverse events, and dropout rates remained low.

Neurocrine's Chief Medical Officer, Eiry Roberts, expressed optimism about the results, emphasizing the need for better treatments for the millions of people living with MDD who do not find adequate relief from current therapies. Roberts highlighted that NBI-1065845 has the potential to provide a breakthrough treatment for symptoms that are not adequately managed by current therapeutic options.

NBI-1065845, initially developed by Takeda, is an investigational positive allosteric modulator of the AMPA receptor. In 2020, Neurocrine entered into a licensing agreement with Takeda, involving an upfront payment of $120 million and potential development milestones amounting to $495 million. The agreement covers the development and commercialization of seven psychiatric programs, including NBI-1065845.

As part of this agreement, Neurocrine is tasked with developing and commercializing the candidates under the deal, while Takeda stands to receive up to $1.4 billion in commercial milestone payments, in addition to potential double-digit royalties on net sales.

However, in November 2023, Neurocrine ceased the development of another program within this collaboration—NBI-1065846—after it did not demonstrate significant effectiveness in reducing anhedonia in a separate Phase II trial, the TERPSIS study, focused on MDD patients.