Helus Pharma Completes Phase 3 HLP003 Enrollment in MDD

NEW YORK and TORONTO, Aug. 14, 2026

HLP003 Phase 3 Program Reaches Key Clinical Milestone

The completion of enrollment in APPROACH, the first pivotal study within the Phase 3 PARADIGM program, represents a major step for HLP003. The company said the study remains on track for a topline data readout in Q4 2026, making the upcoming results a key catalyst for the program. Helus is simultaneously continuing enrollment in EMBRACE, its second pivotal Phase 3 study, while participants are continuing to roll into EXTEND to generate additional information on long-term safety, durability of clinical effects and the potential role of repeat dosing. Earlier Phase 2 findings provided the rationale for advancing HLP003 into Phase 3, with Helus reporting an approximately 23-point reduction in MADRS scores from baseline at 12 months following two 16 mg doses administered three weeks apart. Using a MADRS remission threshold of 10 or below, the company reported 100% response and 71% remission rates at 12 months in that study. These earlier findings are encouraging, but the ongoing Phase 3 program will be important for determining whether the treatment effect can be confirmed in larger pivotal studies.

HLP003 DDI Results Support Development as Adjunctive Therapy

Helus has also completed a drug-drug interaction (DDI) study designed to assess whether HLP003 affects the plasma levels of six tested substrates associated with CYP450 enzymes. According to the company, HLP003 did not meaningfully alter the plasma concentrations of the tested substrates, providing evidence of no significant pharmacokinetic interaction with the enzymes examined. Combined with available literature evidence, Helus believes these findings indicate a low likelihood of pharmacokinetic interactions between HLP003 and commonly used selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). This is particularly relevant to the company’s development strategy because HLP003 is being evaluated as an adjunctive treatment for patients with MDD, where compatibility with existing antidepressant therapies can be an important consideration. Meanwhile, Helus continues to advance HLP004 for generalized anxiety disorder (GAD), with the company planning to complete the design of its next HLP004 study by the end of Q3 2026. Earlier Phase 2 data showed a reported approximately 10-point improvement on the Hamilton Anxiety Rating Scale at six weeks on top of standard of care, while Phase 1 findings indicated short acute effects and a generally favorable tolerability profile.

Helus Expands Pipeline While Preparing for Late-Stage Execution

Beyond HLP003 and HLP004, Helus Pharma is continuing to build a broader proprietary serotonergic agonist pipeline, with HLP005 advancing toward development candidate selection and a candidate anticipated in the second half of 2027. The company also reported a growing intellectual property portfolio comprising more than 350 patent applications and over 100 granted patents worldwide. The appointment of Michael Halstead as CEO comes as Helus enters a period dominated by late-stage clinical execution, particularly the upcoming HLP003 Phase 3 readout and continued development of the PARADIGM program. Financially, Helus reported $166.4 million in cash as of June 30, 2026, while net loss for the quarter was $47.8 million and cash-based operating expenses were $37.5 million. The company said higher operating expenses and cash usage were primarily associated with continued advancement of the APPROACH, EMBRACE and EXTEND Phase 3 studies. Overall, the completion of HLP003 enrollment, continued Phase 3 execution and the upcoming Q4 2026 topline readout place Helus Pharma at an important point in the clinical development of its novel serotonergic therapies.

Source:Helus Pharma, press relese