Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) has announced the publication of Phase 2a trial results for SPL026 in the prestigious journal Nature Medicine. 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 post-dose.
The treatment was generally well tolerated, with no treatment-related serious adverse events reported. Importantly, the benefits were sustained for up to three months in the open-label phase, and some participants maintained response for up to six months. These findings support the 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 focused on developing novel serotonergic agonists (NSAs) designed to activate serotonin pathways believed to promote neuroplasticity. The company aims to address the large unmet need in mental health conditions such as depression and anxiety. Helus Pharma is currently advancing 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. Additionally, HLP004 is in Phase 2 for generalized anxiety disorder.
The positive Phase 2a data for SPL026 marks a significant milestone for Helus Pharma, validating the potential of its NSA platform. The publication in Nature Medicine highlights the scientific credibility of the findings. For more details, the full press release is available at https://ibn.fm/etsES.
Investors can find the latest news and updates relating to HELP in the company’s newsroom at https://ibn.fm/HELP.
