Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (NSAs) for serious 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). 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), with durable response rates and favorable tolerability. The study also featured a short in-clinic treatment experience, supporting continued development for a patient population with limited options.
GAD affects millions worldwide, and many patients remain symptomatic despite standard antidepressant therapy. HLP004, a proprietary NSA, aims to address this unmet need by targeting serotonin pathways believed to promote neuroplasticity. The positive Phase 2 results suggest HLP004 could offer a new adjunctive approach for those who do not adequately respond to existing treatments.
Helus Pharma, the commercial operating name of Cybin Inc., is also developing HLP003 for major depressive disorder, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration and is in Phase 3 trials. The company operates in Canada, the United States, the United Kingdom, and Ireland, and is committed to advancing mental health therapies. For more information, visit www.helus.com or follow the team on X, LinkedIn, YouTube, and Instagram.
The full press release is available at https://ibn.fm/mnw3T. Investors seeking the latest news on HELP can find updates in the company's newsroom at https://ibn.fm/HELP.
This announcement underscores the potential of NSAs to transform mental health treatment, offering hope for patients with GAD who have limited therapeutic options. The Phase 2 data support further clinical development of HLP004, which could become a key addition to the armamentarium against anxiety disorders.
