Helus Hits Full Enrollment in Phase 3 APPROACH Study for Breakthrough Depression Drug HLP003
Helus Pharma (NASDAQ: HELP) has finished enrolling patients in its Phase 3 APPROACH trial of HLP003, a key step that clears the path toward late‑stage data for a Breakthrough‑designated adjunctive treatment in Major Depressive Disorder (MDD).
What HLP003 is aiming to do
HLP003 is an oral new chemical entity being developed as an add‑on (adjunctive) therapy for people with MDD who still have significant symptoms despite taking standard antidepressants. The drug has FDA Breakthrough Therapy Designation, reflecting promising earlier results and the high unmet need in this patient group. In prior studies, HLP003 showed robust, durable reductions in depression scores over 12 months, with high response and remission rates and a favorable safety profile.
The APPROACH Phase 3 trial
APPROACH is one of the pivotal Phase 3 studies in Helus’ PARADIGM program, testing two doses of HLP003 versus placebo as adjunctive treatment in moderate to severe MDD. Completing enrollment means all planned patients are now in the study, and Helus can focus on follow‑up, data collection and analysis without worrying about recruitment delays. Topline results from APPROACH are currently expected in the fourth quarter of 2026, and will be a major clinical and valuation catalyst for the program.
Why full enrollment matters
Enrollment is often the quiet risk in late‑stage trials; once it is complete, timelines become more predictable. For HLP003, finishing enrollment in APPROACH reduces execution risk and keeps the Breakthrough‑designated program on track. If Phase 3 data confirm the strong efficacy and durability seen earlier, HLP003 could move toward a regulatory filing as a new adjunctive option for patients whose current antidepressants aren’t enough, supported by the broader PARADIGM package (APPROACH, EMBRACE and the EXTEND long‑term study).
