Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) today announced the publication of Phase 2a clinical 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 compared to placebo in patients with moderate-to-severe major depressive disorder. The study met its primary endpoint at two weeks, with a mean difference in the Montgomery-Åsberg Depression Rating Scale (MADRS) of -7.35 (p=0.023), and showed effects as early as one week. The treatment was generally well tolerated, with no treatment-related serious adverse events reported.
The publication in Nature Medicine highlights the potential of SPL026, the company's proprietary serotonergic agonist, to provide durable improvements for patients suffering from depression. In the open-label phase, benefits were sustained for up to three months, with some participants maintaining response for up to six months. This data supports the continued development of Helus Pharma's novel serotonergic agonist (NSA) program, including HLP004 for generalized anxiety disorder, which is currently in Phase 2 trials.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company focused on developing proprietary NSAs—synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The company aims to address the large unmet need for people with depression, anxiety, and other mental health conditions. According to the company's press release, Helus Pharma is also developing HLP003 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.
The positive Phase 2a results for SPL026 represent a significant milestone for Helus Pharma, as they validate the potential of its NSA platform to produce rapid and sustained antidepressant effects. The publication in a high-impact journal like Nature Medicine underscores the scientific credibility and importance of these findings. For investors and the broader mental health community, this announcement signals that Helus Pharma is advancing promising treatments that could reshape the therapeutic landscape for depression and anxiety disorders.
For more details on the Phase 2a data, the full press release is available at https://ibn.fm/etsES. Additional information about Helus Pharma and its pipeline can be found on the company's website at www.helus.com.
