Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) announced the publication of Phase 2a trial results in Nature Medicine, showing 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), with effects observed as early as one week. The treatment was generally well tolerated, with no treatment-related serious adverse events.
These findings are important because they provide robust evidence for the potential of SPL026, a proprietary serotonergic agonist, to address the large unmet need for effective treatments in major depressive disorder. The benefits were sustained for up to three months in the open-label phase, with some participants maintaining response for up to six months, supporting continued development of the company’s proprietary serotonergic agonist program, including HLP004 for generalized anxiety disorder.
The publication in a high-impact journal like Nature Medicine underscores the significance of these results and validates the scientific approach of Helus Pharma. The company is focused on developing novel serotonergic agonists (NSAs) that aim to promote neuroplasticity and provide durable improvements in mental health. Helus Pharma is currently advancing HLP003, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, into Phase 3 clinical development for the adjunctive treatment of major depressive disorder, and HLP004 into Phase 2 for generalized anxiety disorder.
For more details, the full press release can be accessed at https://ibn.fm/etsES. Additional information about the company is available at www.helus.com.
