Key Takeaways:
Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) said its APPROACH Phase 3 trial of HLP003 for adjunctive major depressive disorder has surpassed 86% enrollment, keeping the FDA Breakthrough-designated program on track for a topline data readout in the fourth quarter of 2026.
"We are pleased with the continued progress of the APPROACH study as we surpass 86% enrollment," said Eric So, Interim Chief Executive Officer of Helus Pharma. "This milestone underscores the execution of our clinical program and brings us closer to the anticipated topline data readout in the fourth quarter of 2026."
The APPROACH trial is one of three studies in the PARADIGM program, which also includes the EMBRACE study and the EXTEND long-term extension study. In previously reported Phase 2 data, HLP003 showed an approximately 23-point reduction on the Montgomery-Asberg Depression Rating Scale from baseline at 12 months after two 16 mg doses administered three weeks apart. Phase 2 response and remission rates reached 75% at week 18 and improved to 100% and 71%, respectively, at 12 months — though the company notes these results have not been evaluated by the FDA and may not predict Phase 3 outcomes.
HLP003 is a proprietary novel serotonergic agonist designed to activate serotonin pathways believed to promote neuroplasticity, offering a potential alternative to traditional antidepressants that can take weeks to work and leave many patients with inadequate relief. The FDA's Breakthrough Therapy Designation, granted to therapies where preliminary evidence suggests a substantial improvement over available options, allows for more intensive regulatory guidance during development.
The enrollment milestone comes alongside a US$50 million equity offering priced June 24 at US$4.85 per share, with Cantor Fitzgerald and Barclays acting as joint bookrunning managers. The company said proceeds will fund the PARADIGM program, including the APPROACH, EMBRACE and EXTEND studies, as well as development of HLP004 for generalized anxiety disorder and HLP005.
The stock rose 28.9% after the announcement, according to Simply Wall St data, reflecting investor optimism that the trial remains on schedule. The broader depression treatment market is undergoing what analysts describe as its most significant therapeutic transformation in decades, with novel-mechanism drugs reaching late-stage development. Compass Pathways reported positive Phase 3 data for its synthetic psilocybin candidate COMP360 in treatment-resistant depression earlier this year, while Definium Therapeutics in June reported positive topline results from its Phase 3 Emerge study of DT120 in MDD, meeting its primary endpoint with a placebo-adjusted MADRS reduction of 8.1 points at week 6.
The Q4 2026 readout will determine whether HLP003's Phase 2 signal can be reproduced at scale. If successful, the drug would enter a market where roughly one-third of patients with MDD do not achieve adequate relief from existing therapies, representing a potential multibillion-dollar opportunity for an adjunctive treatment requiring only periodic dosing. Investors will watch for completion of enrollment and any safety signals from the ongoing trial in the months ahead.
This article is for informational purposes only and does not constitute investment advice.
