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.
The positive results underscore the potential of SPL026 as a novel therapeutic option for major depressive disorder. Benefits were sustained for up to three months in the open-label phase, with some participants maintaining response up to six months. These findings support continued development of the company’s proprietary serotonergic agonist program, including HLP004 for generalized anxiety disorder. The full press release can be viewed at https://ibn.fm/etsES.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical stage pharmaceutical company focused on developing proprietary novel serotonergic agonists (NSAs) designed to activate serotonin pathways believed to promote neuroplasticity. The company aims to address the large unmet need for people suffering from depression, anxiety, and other mental health conditions. Helus Pharma is currently developing HLP003, a proprietary NSA in Phase 3 clinical development for the adjunctive treatment of major depressive disorder, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. HLP004, another proprietary NSA, is in Phase 2 for generalized anxiety disorder. The company also has an extensive research portfolio of investigational NSAs.
The publication in Nature Medicine represents a significant milestone for Helus Pharma, highlighting the potential of its NSA platform to provide durable improvements in mental health. The company operates in Canada, the United States, the United Kingdom, and Ireland. For more information, visit www.helus.com. The latest news and updates are available in the company's newsroom at https://ibn.fm/HELP.
