HLP003 (previously CYB003) - (APPROACH)

July 21, 2026: Helus Pharma (NASDAQ: HELP; Cboe CA: HELP) announced it completed enrollment in APPROACH, its Phase 3 pivotal trial of HLP003 (an investigational deuterated psilocin analogue with FDA Breakthrough Therapy Designation) as an adjunctive treatment for major depressive disorder (MDD). APPROACH enrolled 223 adults with moderate-to-severe MDD (MADRS ≥24) with inadequate response on a stable antidepressant regimen; participants are randomized 1:1 to HLP003 16 mg or placebo in a two-dose regimen administered three weeks apart. The primary endpoint is change from baseline in MADRS at week 6 versus placebo; the key secondary endpoint is change in MADRS at week 12. Topline data (primary and key secondary endpoints) are on track for Q4 2026.

Program updates: enrollment continues in EMBRACE (the second pivotal Phase 3 study in the PARADIGM program), and participant rollover is ongoing into EXTEND, a blinded long-term extension study evaluating safety, durability, and potential redosing.

The release also cites prior Phase 2 HLP003 data showing a mean ~23-point MADRS reduction 12 months after two 16 mg doses, with 100% response and 71% remission (MADRS ≤10), and notes a potential FDA NDA filing targeted for 2028.