NEW YORK and TORONTO — March 5, 2026 — Leads & Copy —
Helus Pharma (Nasdaq: HELP; Cboe CA: HELP) has announced topline results from a Phase 2 signal detection study evaluating HLP004 as a potential treatment for adults with moderate-to-severe generalized anxiety disorder (GAD). The study focused on patients who remained symptomatic despite ongoing standard of care (SoC) antidepressant therapy.
The clinical-stage pharmaceutical company, which develops novel serotonergic agonists (NSAs) for serious mental health conditions, reported statistically significant (p<0.0001) and clinically meaningful improvement in the Hamilton Anxiety Rating Scale (HAM-A) of approximately 10 points on top of SoC at 6 weeks. These effects were sustained for at least 6 months.
Key findings from the Phase 2 study include:
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Patients receiving 20mg of HLP004 adjunctive to SoC therapy achieved a mean reduction of 10.4 points (p<0.0001) in the HAM-A from baseline at six weeks.
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The study population consisted of moderate-to-severe patients who remained symptomatic despite ongoing antidepressant or anxiolytic therapy.
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At six months, the pooled study population showed 67% responders and 39% remitters.
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Participants randomized to both 20 mg and 2mg dosing arms experienced meaningful subjective effects and showed clinically significant responses over SoC, with 59% meeting the criteria for response and 32% for remission in the 20mg arm and a 30% responder and remitter rate in the 2mg arm at week 6.
The Phase 1 trial indicated most participants were ready for discharge within 3 hours, with acute effects lasting approximately 90 minutes. The treatment was generally well-tolerated, with transient adverse events and no drug-related serious adverse events recorded.
The study involved 36 patients who were randomized 2-to-1 active-to-placebo to either HLP004 20 mg or 2mg and received two intramuscular doses three weeks apart. Patients were followed through Week 12, with continued observational follow-up extending up to one year. Participants had an average baseline HAM-A score of 22 and a General Anxiety Disorder-7 score of greater than or equal to 10 at screening. All study participants continued their SoC medications for generalized anxiety disorder throughout the trial.
The company reported that short in-clinic treatment experience with acute drug effects lasting approximately 90 minutes and discharge readiness within approximately three hours, fitting within the treatment paradigm of existing interventional psychiatry clinics and it is commercially scalable.
Dr. Andrew Cutler, Clinical Professor of Psychiatry at SUNY Upstate Medical University and Senior Advisor to Helus Pharma, noted the magnitude of improvement observed over standard of care treatments, together with the rapid onset and short in-clinic treatment experience.
Michael Cola, Chief Executive Officer of Helus Pharma, stated that the company is encouraged by the data and the potential for HLP004 to bring hope to GAD patients. He also mentioned the company’s plans to release data on HLP003, targeted at major depressive disorder, in the fourth quarter of 2026.
HLP004 is an investigational intramuscular deuterated serotonergic agonist designed to activate serotonin pathways believed to promote neuroplasticity. It is being developed as a potential adjunctive treatment for patients with GAD who remain symptomatic despite existing pharmacologic therapies.
GAD affects more than 20 million adults in the United States, with approximately half of treated patients failing to respond to initial first-line therapy. No adjunctive pharmacologic treatment for GAD has ever been approved, and no new monotherapy has been approved in almost two decades.
Helus Pharma aims to improve the treatment landscape through the introduction of NSAs that aim to provide durable improvements in mental health. Helus Pharma is currently developing HLP003, a proprietary NSA, in Phase 3 clinical development for the adjunctive treatment of major depressive disorder that has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration and HLP004, also a proprietary NSA in Phase 2 for generalized anxiety disorder.
Helus Pharma operates in Canada, the United States, the United Kingdom, and Ireland.
Source: Helus Pharma
