Helus Pharma completes enrollment in Phase 3 APPROACH study of HLP003 for MDD

Helus Pharma, the commercial operating name of Cybin Inc., announced on July 21, 2026 that it had completed enrollment in its APPROACH Phase 3 pivotal study of HLP003 in patients with Major Depressive Disorder.¹ APPROACH enrolled adults with moderate to severe MDD who had an inadequate response despite a stable antidepressant regimen.¹

According to the company, APPROACH completed enrollment of 223 participants with moderate to severe MDD (MADRS ≥ 24) who were on a stable dose of antidepressant medication but responding inadequately.¹ Participants were randomized 1:1 to receive HLP003 at 16 mg or placebo, with each arm following a two-dose regimen administered three weeks apart.¹ The primary endpoint is change from baseline in MADRS score at six weeks after the first dose compared to placebo, with a key secondary endpoint measuring the same at 12 weeks.¹

Completion of enrollment advances the company toward its expected release of topline data in the fourth quarter of 2026.¹ That topline release is set to include both the primary and key secondary endpoints.¹

HLP003 is an investigational deuterated psilocin analogue that has received FDA Breakthrough Therapy Designation, with APPROACH the first pivotal trial to assess it as a potential adjunctive treatment for MDD.¹ Eric So, Interim Chief Executive Officer of Helus Pharma, said the company looks forward to advancing the program toward a potential FDA New Drug Application in 2028.¹

Separately, enrollment continues in EMBRACE, the second pivotal study in the PARADIGM Program, and eligible participants from both APPROACH and EMBRACE may roll over into EXTEND, a long-term extension study evaluating safety, durability and potential redosing.¹