Helus Pharma updates Phase 3 depression and Phase 2 anxiety programs

Helus Pharma Inc. (Nasdaq: HELP; Cboe CA: HELP) gave updates on its two lead programs during an investor presentation held on October 21, 2026. The company reiterated that the APPROACH Phase 3 study topline data readout for HLP003 remains on track for the fourth quarter of 2026, alongside an overview of the competitive landscape in adjunctive treatment of major depressive disorder.¹

Helus Pharma had previously announced completing enrollment of 223 participants in the APPROACH Phase 3 pivotal study in July 2026, with enrollment continuing in EMBRACE, a second pivotal Phase 3 study, and eligible participants from both studies eligible to roll into EXTEND, a long-term extension study examining safety, durability of effect, and potential redosing.¹

HLP003 has received Breakthrough Therapy Designation from the FDA, and the company expects to file a New Drug Application in 2028.¹

For HLP004, the program has shifted focus. Helus Pharma had previously described the HLP004 program as an adjunctive therapy for generalized anxiety disorder, but it is now being developed as a monotherapy, a change the company attributed to its assessment of the current GAD treatment landscape and limitations of existing approved monotherapies.¹

The upcoming Phase 2 study will test two 30 mg doses of HLP004 as monotherapy in a multi-center, randomized, double-blind, placebo-controlled design, enrolling about 144 adult participants in a 1:1 ratio against placebo, with the primary endpoint being change from baseline in HAM-A total score at Week 6 and a key secondary endpoint at Week 12.¹ Eligible participants must have a DSM-5 primary diagnosis of GAD with a minimum HAM-A score of 20 or more at screening and baseline.¹

The company said the next HLP004 Phase 2 monotherapy study is expected to initiate in the first quarter of 2027.¹