Helus Pharma said it completed enrollment ahead of schedule in the Phase 3 study evaluating HLP003 as an adjunctive treatment for major depressive disorder.
- The trial enrolled 223 adults with moderate-to-severe depression.
- The company is on track to report topline results for the investigational therapy in the fourth quarter of 2026
- Helus recently raised $50 million to support the Phase 3 program.
Shares of Helus Pharma (HELP) surged more than 16% to their highest levels since January, after the biotech firm said it has completed enrollment ahead of schedule in the Phase 3 study evaluating HLP003 as an adjunctive treatment for major depressive disorder (MDD).
The milestone keeps the company on track to report topline results in the fourth quarter of 2026 for the investigational therapy, which has received the U.S. Food and Drug Administration’s (FDA) Breakthrough Therapy Designation.
Trial Enrolls 223 Patients
The Approach trial enrolled 223 adults with moderate-to-severe depression who continued to experience symptoms despite taking stable antidepressant medication. Participants were randomized to receive either HLP003 or a placebo in a two-dose regimen administered three weeks apart.
Helus said enrollment is continuing in the Embrace Phase 3 study, while eligible patients from both trials can transition into the Extend long-term study to evaluate the treatment’s safety, durability, and potential for redosing.
HLP003 Aims To Address Unmet Needs in Hard-to-Treat Depression
HLP003 previously delivered encouraging Phase 2 results, showcasing an average 23-point reduction in depression scores one year after treatment. The study also reported a 100% response rate and 71% remission rate under traditional criteria.
The company believes HLP003 could offer a new treatment option for patients who do not respond adequately to standard antidepressants.
Helus Targets NDA By 2028
Helus recently raised $50 million to support the Phase 3 program and plans to use part of the proceeds to advance HLP003 toward a potential New Drug Application (NDA) filing in 2028.
The milestone comes as the U.S. steps up efforts to expand treatment options for depression and other mental health disorders. The FDA recently announced several measures to accelerate the development of psychedelic therapies after President Donald Trump signed an executive order directing federal health agencies to speed up research into treatments such as psilocybin, MDMA, and ibogaine.
Retail Expects Quicker Readout Of HLP003 Topline Data
Retail sentiment surrounding HELP on Stocktwits turned ‘extremely bullish’ from ‘bullish’ a day earlier, amid a 67% increase in message volumes.
One user expects the stock to hit a new 52-week high.
View this Stocktwits post
Another user hopes that the topline results will now be available before Q4.
View this Stocktwits post
The stock is down 0.5% so far this year, significantly underperforming the AdvisorShares Psychedelics ETF’s (PSIL) 40% gains.
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