DFTX Surpasses 86% Enrollment in Phase 3 Depression Trial, Data Due Q4 2026
DFTX•DFTX’s Phase 3 APPROACH trial of HLP003 for adjunctive treatment of major depressive disorder has surpassed 86% patient enrollment, maintaining its FDA Breakthrough Therapy designation. The company remains on track for a topline data readout in the fourth quarter of 2026 after Phase 2 showed a 23-point MADRS score reduction and 100% response at 12 months.
1. Enrollment Milestone
DFTX has enrolled over 86% of the planned participants in its APPROACH Phase 3 study of HLP003 for adjunctive major depressive disorder, marking a key operational achievement. This progress keeps the trial aligned with its projected timeline and regulatory interactions under the FDA’s Breakthrough Therapy pathway.
2. Trial Program Structure
The APPROACH study sits within the PARADIGM Phase 3 program, which also includes the EMBRACE efficacy study and the EXTEND long-term extension. This multi-trial design aims to build a comprehensive safety and efficacy package to support potential FDA approval and commercialization of HLP003.
3. Phase 2 Efficacy Data
In earlier Phase 2 testing, HLP003 delivered an average 23-point reduction on the Montgomery-Åsberg Depression Rating Scale at 12 months following two 16 mg doses three weeks apart. Response and remission rates rose from 75% at week 18 to 100% and 71%, respectively, by the one-year mark.
4. Market Outlook and Next Steps
Major depressive disorder affects hundreds of millions globally and remains underserved by older SSRIs and SNRIs, creating demand for novel, durable treatments. With topline Phase 3 data expected in Q4 2026, DFTX could significantly reshape its valuation depending on the strength of HLP003’s pivotal results.
