Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (NSAs) for serious mental health conditions, today reported topline results from a Phase 2 signal detection study evaluating HLP004 as a potential adjunctive treatment for adults with moderate-to-severe generalized anxiety disorder (GAD) who remained symptomatic despite ongoing standard-of-care antidepressant therapy. The study met its primary endpoint, with patients receiving 20 mg HLP004 alongside standard treatments 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, supporting continued development of the therapy for a patient population with limited treatment options.
These findings are significant because they offer hope for the millions of patients with GAD who do not achieve adequate relief from current antidepressants. According to the company, approximately one-third of patients with GAD remain symptomatic despite first-line treatments, underscoring a substantial unmet medical need. HLP004, a proprietary NSA, is designed to activate serotonin pathways believed to promote neuroplasticity, potentially offering a novel mechanism for anxiety relief. The Phase 2 study enrolled adults with moderate-to-severe GAD who were already on stable antidepressant therapy, reflecting real-world clinical practice. The 10.4-point reduction in HAM-A scores represents a clinically meaningful improvement, and the favorable tolerability profile suggests HLP004 could be a well-tolerated add-on option.
Helus Pharma, the commercial operating name of Cybin Inc., is committed to developing NSAs that aim to provide durable improvements in mental health. The company’s pipeline includes HLP003, a proprietary NSA in Phase 3 clinical development for the adjunctive treatment of major depressive disorder, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. HLP004, also a proprietary NSA, is now advancing 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 more information, visit www.helus.com.
The positive Phase 2 results mark a critical step forward in addressing the treatment gap for GAD. With limited new mechanisms of action approved for anxiety in recent decades, HLP004’s novel serotonergic agonist approach could offer a differentiated therapeutic option. The company plans to discuss the data with regulatory authorities to determine the next steps for clinical development. Investors and stakeholders can access the full press release at https://ibn.fm/mnw3T and stay updated on company news at https://ibn.fm/HELP.
