Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) announced the publication in Nature Medicine of Phase 2a trial results for SPL026, a proprietary serotonergic agonist. The study demonstrated 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 (MDD). The primary endpoint was met 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 reported. 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, which includes HLP004 for generalized anxiety disorder.
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 that promote neuroplasticity. The company aims to address the large unmet need for people suffering from depression, anxiety, and other mental health conditions. Currently, Helus Pharma is developing HLP003, a proprietary NSA in Phase 3 clinical development for adjunctive treatment of MDD, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. HLP004 is in Phase 2 for generalized anxiety disorder, and the company has an extensive research portfolio of investigational NSAs.
The positive Phase 2a data for SPL026 mark a significant milestone, as the results were published in a prestigious peer-reviewed journal and demonstrate durable benefits. This positions Helus Pharma as a leader in the emerging field of psychedelic-inspired therapies for mental health conditions. The full press release can be accessed at https://ibn.fm/etsES.
For more information about Helus Pharma, visit www.helus.com. Latest news and updates are available in the company's newsroom at https://ibn.fm/HELP.
