New Analyses of HLP003 for the Adjunctive Treatment of MDD

Helus Pharma has shared 4 new analyses evaluating HLP003, an investigational oral deuterated psilocin analog being developed as an adjunctive treatment for major depressive disorder (MDD).¹

These analyses included:

• A post hoc analysis of a phase 1/2a study assessing the effects of HLP003 on MADRS individual items and an anhedonia subscale in adults with MDD.
• An assessment of the psychedelic experience in adults with MDD.
• An expanded safety analysis of HLP003.
• A trial-in-progress overview of PARADIGM, the ongoing phase 3 clinical program of HLP003.

About HLP003

HLP003, an investigational novel serotonergic agonist under development at Helus Pharma. HLP003 is a deuterated analogue of psilocin, the active metabolite of psilocybin; deuteration stabilizes the otherwise unstable psilocin molecule, eliminating the need for in vivo conversion from psilocybin before it reaches the brain. Unlike other psychedelic-derived compounds in development that target treatment-resistant depression, which affects only 20% to 25% of patients with MDD, HLP003 targets the larger adjunctive population, comprising 50% to nearly 60% of patients with MDD who show partial but inadequate response to first- or second-line therapy.²

The Phase 3 PARADIGM Program

The phase 3 PARADIGM program consists of:

The APPROACH Study: The first pivotal short-term trial, which completed enrollment of 223 participants with moderate-to-severe MDD in July 2026. It will compare a 16 mg dose of HLP003 to placebo administered 3 weeks apart, with a primary endpoint measuring efficacy at 6 weeks via the Montgomery-Åsberg Depression Rating Scale (MADRS). Top-line data is expected in Q4 2026.

The EMBRACE Study: The second pivotal short-term trial, which is designed to enroll 330 participants, and evaluate 16 mg and 8 mg dose arms alongside a placebo.

The Long-Term Extension (EXTEND): This extension permits participants from the pivotal trials to roll over into a 1-year study to collect extended safety and durability data.

Future Directions

According to Eric So, the interim chief executive officer of Helus Pharma, the company is hoping for a potential FDA New Drug Application in 2028.³

References

1. Helus Pharma presents new analyses on HLP003 in major depressive disorder at Psych Congress 2026. News release. September 21, 2026. Accessed September 21, 2026. https://www.globenewswire.com/news-release/2026/09/21/3365383/0/en/helus-pharma-presents-new-analyses-on-hlp003-in-major-depressive-disorder-at-psych-congress-2026.html

2. Kramer K. HLP003, deuterated psilocin, as an adjunctive therapy for major depressive disorder. Psychiatric Times. August 17, 2026. https://www.psychiatrictimes.com/view/hlp003-deuterated-psilocin-as-an-adjunctive-therapy-for-major-depressive-disorder

3. Helus Pharma completes enrollment in phase 3 APPROACH study of HLP003 in adjunctive treatment of major depressive disorder ahead of schedule. News release. July 21, 2026. Accessed September 21, 2026. https://ir.helus.com/news-releases/news-release-details/helus-pharma-completes-enrollment-phase-3-approach-study-hlp003