Helus Pharma (NASDAQ:HELP) reported positive topline Phase 2 signal-detection results for its investigational therapy HLP004 in adults with moderate-to-severe generalized anxiety disorder (GAD) who remained symptomatic despite standard antidepressant treatment.
The study enrolled 36 patients who received two intramuscular doses of HLP004 or placebo, administered three weeks apart while continuing their existing standard-of-care therapy.
Patients treated with the 20 mg dose of HLP004 showed a statistically significant and clinically meaningful average reduction of 10.4 points on the Hamilton Anxiety Rating Scale after six weeks, compared with placebo. The therapy was evaluated in a population considered difficult to treat due to limited response to conventional medications.
Results also suggested durable benefits. Pooled data showed that 67% of patients were classified as responders and 39% achieved remission at six months. The treatment experience involved approximately 90 minutes of acute effects, with patients typically ready for discharge within about three hours. The study reported no drug-related serious adverse events and a favorable tolerability profile.
The findings highlight the potential for HLP004 as an adjunctive treatment in the generalized anxiety disorder market, where roughly half of patients do not respond to first-line therapies and where no adjunctive medications are currently approved.
The results may also strengthen the broader development strategy of Cybin Inc, which operates Helus Pharma, particularly as it advances next-generation serotonergic treatments for difficult-to-treat mental health conditions.
More about Helus Pharma
Helus Pharma, the commercial operating name of Cybin Inc., develops novel serotonergic agonists (NSAs) aimed at treating serious psychiatric disorders. Its pipeline includes HLP003, currently in Phase 3 trials as an adjunctive therapy for major depressive disorder and granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration, as well as HLP004 in Phase 2 development for generalized anxiety disorder.