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 a potential 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). The study also demonstrated durable response rates, favorable tolerability, and a short in-clinic treatment experience. These results support continued development of the therapy for a patient population with limited treatment options.
Helus Pharma is the commercial operating name of Cybin Inc., founded in 2019. The company is focused on developing proprietary NSAs—synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity. The company aims to address the large unmet need for people who suffer from depression, anxiety, and other mental health conditions.
In addition to HLP004, Helus Pharma is developing 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. The company also 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, visit www.helus.com or follow the team on social media. The full press release is available at https://ibn.fm/mnw3T.
This announcement is significant because generalized anxiety disorder affects millions worldwide, and many patients do not achieve adequate response with current treatments. HLP004, as an adjunctive therapy, could provide a new option for those who remain symptomatic. The positive Phase 2 results signal potential for a novel mechanism of action targeting serotonin pathways, which may offer durable improvements in mental health.
