Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) announced the publication of Phase 2a trial results in Nature Medicine, demonstrating that a single 21.5 mg dose of SPL026 achieved statistically significant and clinically meaningful reductions in depressive symptoms versus placebo in patients with moderate-to-severe major depressive disorder. The study met its primary endpoint at two weeks, with a mean MADRS difference of -7.35 (p=0.023), and effects were observed as early as one week. The treatment was generally well tolerated, with no treatment-related serious adverse events.
Benefits were sustained for up to three months in the open-label phase, with some participants maintaining response up to six months. These results support continued development of the company's proprietary serotonergic agonist program, including HLP004 for generalized anxiety disorder. The full press release can be accessed at https://ibn.fm/etsES.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company focused on developing novel serotonergic agonists (NSAs) designed to activate serotonin pathways believed to promote neuroplasticity. The company aims to address unmet needs in depression, anxiety, and other mental health conditions. Helus Pharma is currently developing HLP003, a proprietary NSA in Phase 3 clinical development for adjunctive treatment of major depressive disorder, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Additionally, HLP004 is in Phase 2 for generalized anxiety disorder, and the company has an extensive research portfolio of investigational NSAs.
The positive data from this Phase 2a trial represents a significant milestone for Helus Pharma, highlighting the potential of its NSA platform to provide durable improvements in mental health. The publication in a high-impact journal like Nature Medicine underscores the scientific validity of the findings. Investors and stakeholders can find the latest news and updates at the company's newsroom at https://ibn.fm/HELP.
