Helus Pharma HLP004 Phase 2 Study Shows Significant Efficacy

Helus Pharma 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 who remained symptomatic despite ongoing SoC antidepressant therapy, including selective serotonin reuptake inhibitors and related agents. In the Phase 2 signal detection study, 36 patients were randomized 2-to-1 active-to-placebo to 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 were already being treated, and continued treatment throughout the trial, with SoC medications for generalized anxiety disorder. The 10-point improvement in anxiety symptoms is above and beyond what was already being seen with SoC treatment. Key findings include: Clinically meaningful efficacy: Patients that received 20mg HLP004 adjunctive to SoC therapy achieved mean reduction of 10.4-points in the HAM-A from baseline at six weeks. Efficacy in difficult to treat population: Study population consisted of moderate-to-severe patients who remained symptomatic despite ongoing antidepressant or anxiolytic therapy. Durable remission and robust response over time: At six months, the pooled study population showed 67% responders and 39% remitters. 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. Commercially scalable clinic time: Short in-clinic treatment experience with acute drug effects lasting approximately 90 minutes and discharge readiness within approximately three hours1, fitting within the treatment paradigm of existing interventional psychiatry clinics. Well tolerated: Favorable tolerability profile with no drug-related serious adverse events or suicidality-related safety signals.