Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists for mental health conditions, reported positive topline results from a Phase 2 signal detection study evaluating HLP004 as an adjunctive treatment for adults with moderate-to-severe generalized anxiety disorder (GAD). The study targeted patients who remained symptomatic despite ongoing standard-of-care antidepressant therapy. According to the company, patients receiving 20 mg HLP004 alongside standard treatments achieved a mean 10.4-point reduction in HAM-A anxiety scores at six weeks (p<0.0001), with durable response rates and favorable tolerability. The short in-clinic treatment experience supports continued development of HLP004 for a patient population with limited treatment options.
Generalized anxiety disorder affects millions worldwide, and many patients do not achieve adequate symptom relief with existing antidepressants. The positive Phase 2 data suggest HLP004 could provide a much-needed adjunctive option. The study's design focused on patients with moderate-to-severe GAD who remained symptomatic despite standard therapy, a group often refractory to current treatments. The statistically significant reduction in anxiety scores and the durability of response indicate that HLP004 may offer sustained benefits.
Helus Pharma, the commercial operating name of Cybin Inc., is developing proprietary NSAs designed to activate serotonin pathways that promote neuroplasticity. The company's lead product, HLP003, is in Phase 3 clinical development for major depressive disorder and has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. HLP004 is also a proprietary NSA in Phase 2 for GAD. The company has an extensive research portfolio of investigational NSAs.
The full press release is available at https://ibn.fm/mnw3T. For more information about Helus Pharma, visit www.helus.com or follow the team on X, LinkedIn, YouTube and Instagram. The company operates in Canada, the United States, the United Kingdom and Ireland.
