Helus Pharma Announces Topline Results in Phase 2 Signal Detection Study for HLP004 in Patients with Generalized Anxiety Disorder

Core Insights - Helus Pharma announced topline results from a Phase 2 study of HLP004 for treating generalized anxiety disorder (GAD), showing significant improvement over standard treatments [5][9][11] Company Overview - Helus Pharma is a clinical-stage pharmaceutical company focused on developing novel serotonergic agonists (NSAs) for serious mental health conditions [14][15] - The company operates in Canada, the United States, the United Kingdom, and Ireland [16] Study Details - The Phase 2 study involved 36 patients with moderate-to-severe GAD who were symptomatic despite ongoing standard of care (SoC) antidepressant therapy [7][9] - Participants received either 20 mg or 2 mg of HLP004, with a follow-up period extending to one year [7][9] Efficacy Results - A statistically significant improvement of approximately 10 points on the Hamilton Anxiety Rating Scale (HAM-A) was observed at 6 weeks, with durable effects sustained for at least 6 months [9][17] - At six months, 67% of participants were responders and 39% were in remission [9][17] Treatment Profile - HLP004 demonstrated a rapid onset of action, with acute effects lasting around 90 minutes and patients ready for discharge within approximately three hours [9][17] - The treatment was generally well-tolerated, with no serious adverse events reported [9][17] Future Developments - The company plans to advance the development of HLP004 and is also preparing to release data on HLP003, aimed at major depressive disorder, in Q4 2026 [12][15]