Helus Pharma Reports Strong Enrollment Progress in Phase 3 Trial of HLP003 for Major Depressive Disorder

APPROACH Phase 3 Study Crosses 86% Enrollment Milestone

Helus Pharma has announced that patient enrollment in its Phase 3 APPROACH clinical trial of HLP003 has now surpassed 86%, keeping the study on track for a topline data readout in the fourth quarter of 2026.
The study is evaluating HLP003 as an adjunctive treatment for patients living with major depressive disorder (MDD). HLP003 is the company’s lead investigational therapy and has already received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA).
According to the company, the latest enrollment milestone reflects continued progress in the clinical development program and brings the study closer to completion.

HLP003 Continues to Advance Through Late-Stage Development

The APPROACH trial is one of several Phase 3 studies included in Helus Pharma’s broader PARADIGM clinical development program.
The program is designed to evaluate the efficacy, safety, and long-term potential of HLP003 in patients with major depressive disorder. In addition to APPROACH, the PARADIGM program includes the EMBRACE study and the EXTEND long-term extension study.
Together, these trials are intended to support the future regulatory and commercial pathway for HLP003.
Eric So, Interim Chief Executive Officer of Helus Pharma, said the company is pleased with the progress being made and remains focused on delivering a new treatment option for patients struggling with depression.
He noted that crossing the 86% enrollment mark is an important milestone as the company moves toward the anticipated Phase 3 data release next year.

Previous Phase 2 Results Showed Durable Improvements

The ongoing Phase 3 program is supported by encouraging data from earlier Phase 2 studies of HLP003.
Previously reported results showed that patients experienced an approximately 23-point reduction in Montgomery-Asberg Depression Rating Scale (MADRS) scores compared with baseline measurements.
The improvement was observed 12 months after patients received two 16 mg doses of HLP003 administered three weeks apart.
The findings suggested that the treatment may provide long-lasting benefits for individuals living with major depressive disorder.

Response and Remission Rates Improved Over Time

The Phase 2 data also demonstrated strong response and remission rates over an extended follow-up period.
At Week 18, both response and remission rates reached 75%.
The benefits continued to improve over time. By the 12-month follow-up period, the response rate had increased to 100%, while the remission rate reached 71%.
These results have generated interest in HLP003 as a potential new treatment approach for depression, particularly for patients who continue to experience symptoms despite existing therapies.

FDA Previously Granted Breakthrough Therapy Designation

HLP003 has already received Breakthrough Therapy Designation from the FDA, a status granted to investigational therapies that show the potential to offer substantial improvement over currently available treatments for serious conditions.
The designation is intended to help speed up the development and review process for promising therapies.
The recognition highlights the potential importance of HLP003 in addressing the significant unmet needs that remain in major depressive disorder treatment.

Focus on Novel Serotonergic Agonists

Helus Pharma is developing a pipeline of novel serotonergic agonists, also known as NSAs.
These synthetic compounds are designed to activate serotonin pathways in the brain, which are believed to play an important role in promoting neuroplasticity and improving mental health outcomes.
The company is currently advancing HLP003 in Phase 3 development for major depressive disorder while also developing HLP004, another proprietary NSA candidate, in Phase 2 studies for generalized anxiety disorder.
Helus Pharma believes these therapies could help reshape treatment options for depression, anxiety, and other mental health conditions by delivering durable and meaningful improvements for patients.

Company Remains on Track for Q4 2026 Data Readout

With enrollment now exceeding 86%, Helus Pharma says the APPROACH study continues to progress according to plan.
The company remains on track to report topline Phase 3 results during the fourth quarter of 2026, a key milestone that could help determine the future regulatory pathway for HLP003 and its potential role in the treatment of major depressive disorder.

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