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Nature Medicine Publishes Helus Pharma's Randomized, Placebo-Controlled Phase 2a Trial of SPL026 in Major Depressive Disorder
Randomized, placebo-controlled Phase 2a study of SPL026 met its primary endpoint demonstrating a ...
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[{"type":"text","content":"Nature Medicine Publishes Helus Pharma’s Randomized, Placebo-Controlled Phase 2a Trial of SPL026 in Major Depressive Disorder\nRandomized, placebo-controlled Phase 2a study of SPL026 met its primary endpoint demonstrating a clinically significant reduction in depressive symptoms as measured by MADRS score (mean difference: -7.35) versus placebo at two weeksAntidepressant treatment effects observed within one week and sustained for up to three months Findings reinforce the therapeutic potential of short-acting serotonergic agonists and inform Helus Pharma’s HLP004 development program, with Phase 2 topline data in generalized anxiety disorder (“GAD”) expected in Q1 2026 This news release constitutes a “designated news release” for the purpose of the Company’s prospectus supplement dated December 30, 2025, to it short form base shelf prospectus dated September 17, 2025, as amended on December 19, 2025. BOSTON and TORONTO, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Helus Pharma™ (Nasdaq: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (“NSAs”) for serious mental health conditions, today announced the publication1 in Nature Medicine of results from a Phase 2a randomized, placebo-controlled clinical trial evaluating SPL026, in participants with moderate-to-severe major depressive disorder (“MDD”). The study met its primary endpoint demonstrating statistically significant and clinically meaningful reductions in depressive symptoms at two weeks, as measured by the Montgomery-Åsberg Depression Rating Scale (“MADRS”) in participants treated with SPL026 compared with placebo. Reductions in depressive symptoms were observed as early as one week following dosing and were sustained at three months, with effects lasting up to six months in some participants. The treatment was generally well tolerated, with no treatment-related serious adverse events reported. “We have shown that a single dose of SPL026 is safe, effective and durable, with treatment effects comparable to other promising interventional treatments often requiring much longer treatment sessions.” Dr David Erritzoe, from Imperial’s Department of Brain Sciences, and lead investigator of the trial continued, “A...