Curated News
By: NewsRamp Editorial Staff
February 17, 2026

Helus Pharma's SPL026 Shows Promising Results in Major Depression Trial

Original Source

TLDR

  • Helus Pharma's SPL026 Phase 2a trial results demonstrate a clinical advantage for treating depression, potentially positioning the company as a leader in novel serotonergic agonist development.
  • A single 21.5 mg dose of SPL026 achieved statistically significant reductions in depressive symptoms versus placebo, with effects observed as early as one week and sustained up to six months.
  • This treatment offers durable improvements for patients with major depressive disorder, addressing a large unmet need and potentially transforming mental health care for millions worldwide.
  • Helus Pharma's novel serotonergic agonist shows promise for treating depression with sustained effects, while their HLP004 program targets generalized anxiety disorder in ongoing clinical development.

Impact - Why it Matters

This development represents a potential paradigm shift in mental health treatment, offering hope to millions suffering from treatment-resistant depression. Current antidepressants often take weeks to show effects and have significant side effects, leaving many patients without adequate relief. Helus Pharma's approach with novel serotonergic agonists like SPL026, which demonstrated rapid and sustained benefits with good tolerability, could transform how depression is treated. Given that depression affects over 280 million people globally and is a leading cause of disability worldwide, effective new treatments could reduce healthcare costs, improve workplace productivity, and most importantly, alleviate human suffering. The sustained effects observed up to six months suggest these treatments might offer longer-lasting relief than current options, potentially reducing the burden of chronic medication management for patients.

Summary

Helus Pharma, the commercial operating name of Cybin Inc., has achieved a significant breakthrough in mental health treatment with the publication of Phase 2a trial results in the prestigious journal Nature Medicine. The study demonstrated that a single 21.5 mg dose of SPL026, the company's investigational drug, produced statistically significant and clinically meaningful reductions in depressive symptoms compared to placebo in patients with moderate-to-severe major depressive disorder. The treatment met its primary endpoint at two weeks with a mean MADRS difference of -7.35 and showed effects as early as one week, while being generally well-tolerated with no treatment-related serious adverse events. Remarkably, benefits were sustained for up to three months in the open-label phase, with some participants maintaining response up to six months, supporting continued development of the company's proprietary serotonergic agonist program.

The company, which operates in Canada, the United States, the United Kingdom and Ireland, is developing novel serotonergic agonists (NSAs) designed to activate serotonin pathways believed to promote neuroplasticity. Helus Pharma aims to address the large unmet need for people suffering from depression, anxiety, and other mental health conditions through these innovative treatments. The company's pipeline includes HLP003, currently in Phase 3 clinical development for adjunctive treatment of major depressive disorder with Breakthrough Therapy Designation from the FDA, and HLP004 for generalized anxiety disorder in Phase 2 trials. For more details, readers can view the full press release at https://ibn.fm/etsES or visit the company's website at www.helus.com to learn more about Helus Pharma.

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Source Statement

This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Helus Pharma's SPL026 Shows Promising Results in Major Depression Trial

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