Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) has reported positive results from its Phase 2a clinical trial of SPL026, published in the peer-reviewed journal Nature Medicine. The study showed 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 (MDD). The trial met its primary endpoint at two weeks, with a mean difference of -7.35 on the Montgomery-Åsberg Depression Rating Scale (MADRS) (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. Notably, 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 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 for people suffering from depression, anxiety, and other mental health conditions. Helus Pharma is currently advancing HLP003, a proprietary NSA in Phase 3 clinical development for the 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, and the company has an extensive research portfolio of investigational NSAs.
The full press release can be viewed at https://ibn.fm/etsES. For more information about Helus Pharma, visit www.helus.com or follow the team on social media. The latest news and updates are available in the company's newsroom at https://ibn.fm/HELP.
The publication of these results in a high-impact journal like Nature Medicine underscores the potential significance of SPL026 in the treatment of MDD. The durability of response, with benefits lasting up to six months in some participants, suggests that a single-dose approach could offer a long-lasting therapeutic option compared to daily oral medications. This could represent a paradigm shift in how major depressive disorder is managed, particularly for patients who have not responded well to existing treatments.
Helus Pharma operates in Canada, the United States, the United Kingdom, and Ireland. The company’s focus on NSAs aims to improve the treatment landscape through molecules that provide durable improvements in mental health. With class-leading data, Helus Pharma is positioned to address the large unmet need in mental health care.
