Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists for serious 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. Results showed that 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), indicating a statistically significant and clinically meaningful improvement.
The study also demonstrated durable response rates, favorable tolerability, and a short in-clinic treatment experience, supporting continued development of the therapy. These findings are particularly important for the large population of GAD patients who do not achieve adequate relief with current antidepressants. According to the company, HLP004 represents a potential new option that could offer rapid and sustained benefits without the side effects associated with existing treatments.
Helus Pharma, the commercial operating name of Cybin Inc., is focused on developing proprietary NSAs—synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity. The company’s pipeline includes 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. HLP004 is being developed specifically for GAD, and the company also has an extensive research portfolio of investigational NSAs.
The positive Phase 2 results for HLP004 could significantly impact the treatment landscape for GAD. Current options often provide incomplete relief or cause intolerable side effects, leading to high rates of treatment discontinuation. By offering a novel mechanism of action with a favorable tolerability profile, HLP004 may address this unmet need. The company plans to advance HLP004 into later-stage trials to further evaluate its efficacy and safety.
For more details on the press release, visit https://ibn.fm/mnw3T. Additional information about Helus Pharma and its pipeline is available at https://www.helus.com. Investors can find the latest news and updates on the company’s newsroom at https://ibn.fm/HELP.
These results mark a significant step forward in the development of HLP004, offering hope to millions of GAD patients who have not responded adequately to existing therapies. Continued research will be crucial to confirming these benefits and bringing a new treatment option to market.
