Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (NSAs) for mental health conditions, announced positive topline results from its Phase 2 signal detection study evaluating HLP004 as an adjunctive treatment for adults with moderate-to-severe generalized anxiety disorder (GAD). The study enrolled patients who remained symptomatic despite ongoing standard-of-care antidepressant therapy. Patients receiving 20 mg HLP004 alongside standard treatments achieved a mean 10.4-point reduction in the Hamilton Anxiety Rating Scale (HAM-A) scores at six weeks (p<0.0001). The study also demonstrated durable response rates, favorable tolerability, and a short in-clinic treatment experience. These findings support continued development of HLP004 for a patient population with limited treatment options.
The full press release is available at https://ibn.fm/mnw3T. Helus Pharma is the commercial operating name of Cybin Inc., founded in 2019. The company focuses on developing proprietary NSAs—synthetic molecules designed to activate serotonin pathways that promote neuroplasticity—to address unmet needs in depression, anxiety, and other mental health conditions. Helus Pharma is also developing HLP003, a proprietary NSA in Phase 3 for major depressive disorder, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Additionally, the company has an extensive research portfolio of investigational NSAs.
The positive Phase 2 results for HLP004 are particularly significant given the high prevalence of GAD and the limited efficacy of existing treatments for many patients. Current standard-of-care antidepressants often provide incomplete relief, leaving a substantial number of patients with residual symptoms. HLP004, as an adjunctive therapy, offers a potential new option that could improve outcomes without requiring patients to discontinue their current medications. The study's findings of durable response rates and favorable tolerability suggest that HLP004 could be a well-tolerated addition to existing treatment regimens.
Investors can find the latest news and updates regarding HELP at the company's newsroom: https://ibn.fm/HELP. Helus Pharma operates in Canada, the United States, the United Kingdom, and Ireland. More information is available at www.helus.com. The company's proprietary NSAs aim to provide durable improvements in mental health, potentially transforming the treatment landscape for serious mental health conditions.
