Helus Pharma announced publication in Nature Medicine of Phase 2a trial results 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 treatment met the primary endpoint at two weeks with a mean difference of -7.35 (p=0.023), with effects appearing as early as one week.
The drug was generally well tolerated with no treatment-related serious adverse events reported. 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.
Helus Pharma, the commercial operating name of Cybin Inc., is developing proprietary novel serotonergic agonists designed to activate serotonin pathways believed to promote neuroplasticity. The company is currently developing HLP003, a proprietary NSA in Phase 3 clinical development for the adjunctive treatment of major depressive disorder that has received Breakthrough Therapy Designation from the FDA. The company is also advancing HLP004, a proprietary NSA in Phase 2 for generalized anxiety disorder.
The company operates in Canada, the United States, the United Kingdom and Ireland. According to the press release, HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, indicating recognition of its potential as a significant advance in treatment for major depressive disorder.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://menafn.com/1110753282/Psychedelicnewsbreaks-Helus-PharmaTM-NASDAQ-HELP-Cboe-CA-HELP-Reports-Positive-Phase-2A-SPL026-Data-Published-In-Nature-Medicine