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.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical stage pharmaceutical company 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.
The company 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. Additionally, HLP004, another proprietary NSA, is in Phase 2 for generalized anxiety disorder. Helus Pharma also has an extensive research portfolio of investigational NSAs.
For more details, the full press release is available at https://ibn.fm/etsES. The latest news and updates are available in the company’s newsroom at https://ibn.fm/HELP.
