SAN DIEGO - Neurocrine (NASDAQ:NBIX) Biosciences, Inc. (NASDAQ:NBIX) announced today that its Phase 2 study for the investigational drug NBI-1065845 has met its primary endpoint, showing a statistically significant reduction in depression symptoms in adults with major depressive disorder (MDD). The study, termed the SAVITRI™ study, is a randomized, double-blind, placebo-controlled dose-finding trial aimed at evaluating the efficacy and safety of NBI-1065845.
The SAVITRI™ study enrolled 183 adults diagnosed with MDD who had not responded adequately to at least one antidepressant treatment. The results indicated that the once-daily oral administration of NBI-1065845 led to a statistically significant change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) total score at Day 28 and Day 56. Specifically, one of the doses showed an improvement over placebo of -4.3 at Day 28 and -7.5 at Day 56, while the other dose exhibited a trend towards improvement.
According to the press release, NBI-1065845 was generally well-tolerated with the most common adverse event being headache. The adverse event profile for both doses was comparable to placebo, with no deaths or serious adverse events reported, and low discontinuation rates throughout the study.
Dr. Eiry W. Roberts, Chief Medical Officer at Neurocrine Biosciences, expressed optimism about the potential of NBI-1065845 as a first-in-class treatment for MDD symptoms. The company plans to discuss a path into Phase 3 studies with the FDA.
NBI-1065845 is an alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) positive allosteric modulator (PAM) and is part of a strategic collaboration with Takeda (TSE:4502/NYSE:TAK) that began in 2020. Takeda may opt out of a 50:50 profit share arrangement at certain development stages, which would then make it ineligible for development or commercial milestone payments for NBI-1065845.
MDD is a debilitating mental health disorder affecting more than 21 million people in the U.S., with approximately one-third not responding to available antidepressants. Additional data from the SAVITRI™ study will be shared at a future scientific conference.
This report is based on a press release statement from Neurocrine Biosciences, Inc.
InvestingPro Insights
Following the positive news from Neurocrine Biosciences regarding their SAVITRI™ study, investors are keenly observing the company's financial health and growth prospects. According to real-time data from InvestingPro, Neurocrine Biosciences has a market capitalization of $13.44 billion and exhibits a Price/Earnings (P/E) ratio of 51.98. This valuation adjusts to a more attractive P/E ratio of 39.43 when considering earnings over the last twelve months as of Q4 2023. The company's revenue growth is also notable, with a 26.76% increase over the same period, reflecting a strong upward trend in its financial performance.
InvestingPro Tips highlight that Neurocrine Biosciences is expected to see net income growth this year, which aligns with the company's successful clinical trial outcomes and potential for expanding its product portfolio. Furthermore, the company is trading at a low P/E ratio relative to near-term earnings growth, suggesting an opportunity for value investors. It's also worth noting that Neurocrine Biosciences operates with a moderate level of debt and has liquid assets that exceed short-term obligations, indicating a solid financial position.
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