Little information has emerged about osavampator, a potentially first-in-class drug, since its promising Phase II performance last spring.
Neurocrine Biosciences on Monday announced that it will now have the exclusive worldwide right to develop and commercialize the drug candidate osavampator, which it had been developing with Takeda for major depressive disorder patients with subpar response to treatments.
The news comes amid an amended contract between Neurocrine and Takeda. The partners first entered into a neuroscience-focused pact in 2020 to advance a handful of the Japanese pharma’s pipeline assets for psychiatric indications, including schizophrenia, anhedonia and treatment-resistant depression. Neurocrine made a $120 million upfront payment at the time along with the promise of up to $495 million in developmental milestones and up to $1.4 billion in commercial milestones.
The partnership has returned mixed results. In November 2023, for instance, Neurocrine was forced to drop one of the assets from Takeda—dubbed NBI-1065846—after a disappointing Phase II performance in major depressive disorder (MDD).
In April 2024, however, Neurocrine notched a mid-stage win with another asset under the collaboration. A once-daily oral dose of NBI-1065845, also known as osavampator, significantly eased depression symptoms versus placebo in MDD patients, Neurocrine touted at the time, adding that the drug did not trigger serious adverse events.
In an SEC filing on Monday, Neurocrine revealed that it will have ownership over osavampator across all indications in all territories worldwide except Japan, where Takeda will have exclusive development and commercialization rights. Each company will be responsible for the associated development costs for osavampator in their respective territories. The companies will also be entitled to royalties on sales made in their partners’ territories.
In a note to investors, Stifel analysts called the amendment to the Takeda deal “unsurprising given [Takeda’s] pivot away from neuropsych” and the substantial investment that the Japanese pharma would have needed to make to support a Phase III program for osavampator. The firm views this development as an “incremental positive” for Neurocrine, giving it “greater control over a high-value asset.”
The Stifel analysts consider osavampator a “high-risk/high-reward asset,” pointing to its promising Phase II readout in April 2024, but noting that “there’s been limited disclosure since.” Osavampator is set to start Phase III testing in the first half of 2025, according to the Stifel note.
Designed to be orally administered, osavampator is a potentially first-in-class positive allosteric modulator of the AMPA receptors, a drug class that has been shown to have therapeutic promise in MDD.
