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 MADRS difference of -7.35 and demonstrated effects as early as one week. The treatment was generally well tolerated with no treatment-related serious adverse events, and 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 committed to helping minds heal by developing proprietary NSAs – novel serotonergic agonists: synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The company's proprietary NSAs are intended to address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions.
With class leading data, Helus Pharma aims to improve the treatment landscape through the introduction of NSAs that aim to provide durable improvements in mental health. Helus Pharma 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 U.S. Food and Drug Administration and HLP004, also a proprietary NSA in Phase 2 for generalized anxiety disorder. Additionally, Helus Pharma has an extensive research portfolio of investigational NSAs.
The company operates in Canada, the United States, the United Kingdom and Ireland. For company updates and to learn more about Helus Pharma, visit www.helus.com. The latest news and updates relating to HELP are available in the company's newsroom at https://ibn.fm/HELP. PsychedelicNewsWire is a specialized communications platform with a focus on all aspects of psychedelics and the latest developments and advances in the psychedelics sector. For more information, please visit https://www.PsychedelicNewsWire.com.
