Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (NSAs) for mental health conditions, reported positive 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). The study enrolled patients who remained symptomatic despite ongoing standard-of-care antidepressant therapy. Patients receiving 20 mg HLP004 alongside standard treatments achieved a mean 10.4-point reduction in HAM-A anxiety scores at six weeks (p<0.0001), demonstrating statistical significance. The study also showed durable response rates, favorable tolerability, and a short in-clinic treatment experience, supporting continued development of the therapy.
Generalized anxiety disorder affects millions worldwide, and many patients do not achieve adequate symptom relief with existing antidepressants. The positive Phase 2 results suggest HLP004 could offer a new option for these patients. The company noted that the treatment was well-tolerated, with no unexpected safety signals. Helus Pharma is now planning further clinical development for HLP004, which is a proprietary NSA designed to activate serotonin pathways believed to promote neuroplasticity.
Helus Pharma, the commercial operating name of Cybin Inc., founded in 2019, is committed to developing NSAs to address unmet needs in mental health. The company has a robust pipeline, including HLP003, a proprietary NSA in Phase 3 for major depressive disorder, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. The full press release can be accessed at https://ibn.fm/mnw3T.
With class-leading data, Helus Pharma aims to improve the treatment landscape through NSAs that provide durable improvements in mental health. The company operates in Canada, the United States, the United Kingdom, and Ireland. For more information, visit www.helus.com.
