Neurocrine’s Depression Drug Fails to Meet Primary Endpoint in Phase II Trial
San Carlos, CA – November 12, 2024 – Neurocrine Biosciences shares tumbled today after the company announced its investigational drug, NBI-1008, did not achieve statistically significant results in a Phase II clinical trial evaluating its efficacy as a treatment for major depressive disorder (MDD). The setback casts uncertainty over the future development of the novel compound, designed to target the neurokinin 3 (NK3) receptor.
The double-blind, placebo-controlled study involved 164 adult patients diagnosed with MDD. While NBI-1008 demonstrated a favorable safety profile, it failed to demonstrate a statistically significant betterment in depressive symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to the placebo group. This outcome impacts Neurocrine’s pipeline and the potential for a new mechanism of action in treating a condition affecting millions worldwide.
Neurocrine initiated the Phase II trial in February 2024, hoping to validate preclinical data suggesting NK3 receptor modulation could offer a novel approach to depression treatment. Existing antidepressants often fail to provide adequate relief for a substantial portion of patients, fueling the search for option therapies. The company is currently analyzing the full data set from the trial to determine next steps, which may include further investigation of specific patient subgroups or discontinuation of development.
“We are disappointed with these results,” stated Dr. Einarsson,Chief Scientific Officer of Neurocrine Biosciences,in a company press release. “We will thoroughly evaluate the data to understand the implications for the future development of NBI-1008.”
The news sent neurocrine’s stock price down sharply in after-hours trading. investors are closely watching to see how the company will adjust its strategy in the wake of this clinical trial outcome. The failure also highlights the inherent risks associated with pharmaceutical development, even for companies with established expertise in neuroscience.
