NEW YORK and TORONTO, July 21, 2026
Helus Pharma has announced the successful completion of patient enrollment ahead of schedule in the APPROACH Phase 3 pivotal study evaluating HLP003 as an adjunctive treatment for Major Depressive Disorder (MDD). The milestone advances the company’s PARADIGM Phase 3 clinical program, with topline data expected in the fourth quarter of 2026, while enrollment continues in the second pivotal EMBRACE study and eligible participants transition into the EXTEND long-term extension study for additional safety and durability assessments. The investigational therapy has previously received FDA Breakthrough Therapy Designation, reflecting its potential to address a significant unmet need among patients who continue to experience depressive symptoms despite ongoing antidepressant therapy. The achievement marks an important step toward the potential development of a novel treatment option for individuals living with moderate to severe depression.
Early Enrollment Completion Strengthens Phase 3 Development Program
The APPROACH Phase 3 trial enrolled 223 adults with moderate-to-severe Major Depressive Disorder who continued to experience inadequate symptom control despite stable antidepressant treatment. Participants were randomized to receive either HLP003 (16 mg) or placebo using a two-dose regimen administered three weeks apart, with the primary endpoint evaluating changes in Montgomery-Åsberg Depression Rating Scale (MADRS) scores six weeks after the first dose. Completion of enrollment ahead of schedule demonstrates efficient clinical execution while maintaining patient eligibility standards comparable to those achieved during the company’s earlier Phase 2 study. Helus Pharma stated that the rapid enrollment reflects strong collaboration among investigators, research sites, and clinical partners while keeping the program on track for the planned Q4 2026 topline data release.
HLP003 Shows Potential for Durable Depression Treatment
HLP003 is an investigational deuterated psilocin analogue developed as a novel serotonergic agonist (NSA) intended for adjunctive treatment of Major Depressive Disorder. Earlier Phase 2 clinical data demonstrated encouraging long-term efficacy, including an approximately 23-point mean reduction in MADRS scores one year after two doses administered three weeks apart. The study also reported 100% response rates and 71% remission rates using conventional MADRS criteria, with remission increasing further under more recent peer-study benchmarks. These promising findings contributed to the therapy receiving FDA Breakthrough Therapy Designation, supporting accelerated clinical development. Unlike conventional daily adjunctive therapies that may be associated with metabolic complications, movement disorders, sedation, and treatment discontinuation, HLP003 is being investigated as an intermittent adjunctive therapy designed to provide durable clinical benefit while reducing treatment burden for patients with difficult-to-treat depression.
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PARADIGM Program Advances Toward Key Clinical Milestones
Beyond the completed APPROACH enrollment, Helus Pharma continues recruiting participants into EMBRACE, the second pivotal Phase 3 study within the broader PARADIGM Program, while eligible participants are rolling over into the EXTEND long-term extension study to generate additional data on long-term safety, durability of response, and potential redosing strategies. The PARADIGM clinical program has been designed to align with current FDA guidance through rigorous placebo-controlled evaluation, comprehensive safety monitoring, and extended clinical follow-up. Supported by an expanding intellectual property portfolio comprising more than 350 patent applications and over 100 granted patents worldwide, Helus Pharma continues advancing its pipeline of novel serotonergic agonists targeting depression, anxiety, and other mental health disorders. With enrollment now complete in APPROACH and major clinical milestones approaching, the company remains focused on generating robust evidence that could support future regulatory submissions and expand treatment options for patients living with Major Depressive Disorder.
Source: Helus Pharma Press release
