Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), the commercial operating name of Cybin Inc., announced on June 24, 2026, that its APPROACH Phase 3 trial of HLP003 for the adjunctive treatment of major depressive disorder (MDD) has surpassed 86% enrollment. The trial is progressing as planned, keeping the FDA Breakthrough-designated program on track for a topline data readout in the fourth quarter of 2026.
Enrollment Milestone Underscores Clinical Execution
“We are pleased with the continued progress of the APPROACH study as we surpass 86% enrollment,” said Eric So, Interim Chief Executive Officer of Helus Pharma. “This milestone underscores the execution of our clinical program and brings us closer to the anticipated topline data readout in the fourth quarter of 2026. We remain focused on advancing HLP003 as a potential transformative treatment option for patients living with MDD.”
APPROACH is one of the company’s Phase 3 studies evaluating HLP003, its lead proprietary novel serotonergic agonist (NSA). The trial is part of a broader Phase 3 program called PARADIGM, which also includes the EMBRACE study and the EXTEND long-term extension study. This multi-trial structure is designed to build the efficacy and safety package required to advance HLP003 toward potential commercialization.
HLP003 and Breakthrough Therapy Designation
Helus describes its proprietary NSAs as synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity—the brain’s capacity to form new neural connections. The goal is to deliver durable improvements rather than the symptom-by-symptom maintenance of traditional antidepressants. HLP003 is the lead candidate, now in Phase 3 for the adjunctive treatment of MDD. The company is also developing HLP004, an NSA in Phase 2 for generalized anxiety disorder, alongside a broader portfolio of investigational NSAs.
The FDA’s Breakthrough Therapy Designation, granted to HLP003, is reserved for investigational therapies intended to treat serious conditions where preliminary clinical evidence suggests a substantial improvement over available options. The designation expedites development and review through more intensive FDA guidance, signaling regulatory engagement and perceived promise, though it does not guarantee approval.
Phase 2 Results Show Promise
Company-reported Phase 2 results showed a reduction of approximately 23 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline at 12 months after two 16 mg doses administered three weeks apart. Response and remission rates were 75% at week 18, improving to 100% response and 71% remission at 12 months. These figures have not been evaluated by the FDA.
With enrollment now past 86%, Helus Pharma remains focused on completing the APPROACH trial and reporting topline data in Q4 2026, which could mark a significant step forward in the treatment of major depressive disorder.
