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 is available at https://ibn.fm/etsES.
Helus Pharma 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 the unmet need for people with depression, anxiety, and other mental health conditions. Helus Pharma is currently developing HLP003, a proprietary NSA in Phase 3 for major depressive disorder with Breakthrough Therapy Designation from the U.S. Food and Drug Administration, and HLP004 in Phase 2 for generalized anxiety disorder.
The publication of these results in a high-impact journal like Nature Medicine underscores the significance of the data and the potential of SPL026 to offer a new treatment option for major depressive disorder. The sustained benefits observed for up to six months suggest that a single dose could provide long-lasting relief, which is a notable advancement over current treatments that require daily dosing.
For more information about Helus Pharma, visit www.helus.com.
