Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (NSAs) for mental health conditions, reported topline results from a Phase 2 signal detection study evaluating HLP004 as an adjunctive treatment for adults with moderate-to-severe generalized anxiety disorder (GAD) who remained symptomatic despite standard-of-care antidepressant therapy. The study met its primary endpoint, with patients receiving 20 mg HLP004 achieving a mean 10.4-point reduction in HAM-A anxiety scores at six weeks (p<0.0001). The results also demonstrated durable response rates, favorable tolerability, and a short in-clinic treatment experience, indicating potential for a patient population with limited options.
GAD affects millions worldwide, and many patients do not achieve adequate response with current antidepressants. HLP004, a proprietary NSA, aims to activate serotonin pathways to promote neuroplasticity, offering a novel mechanism. The company highlighted that the positive data supports continued development of HLP004 as a potential adjunctive therapy. Helus Pharma is also developing HLP003, a Phase 3 NSA for major depressive disorder that received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. The company operates in Canada, the United States, the United Kingdom, and Ireland. For more details, visit https://ibn.fm/mnw3T.
Helus Pharma, the commercial operating name of Cybin Inc., is committed to helping minds heal by developing NSAs designed to address unmet needs in depression, anxiety, and other mental health conditions. The company's proprietary NSAs aim to provide durable improvements in mental health. With class-leading data, Helus Pharma seeks to improve the treatment landscape. The company also has an extensive research portfolio of investigational NSAs. For updates, visit www.helus.com or follow on social media. The latest news on HELP is available at https://ibn.fm/HELP.
