Helus Pharma’s HLP004 Shows Promise in Treating Generalized Anxiety Disorder
Helus Pharma (HELP) announced positive topline results from a Phase 2 signal detection study evaluating HLP004 as a potential treatment for adults with moderate-to-severe generalized anxiety disorder (GAD) who continue to experience symptoms despite ongoing treatment with standard-of-care antidepressants, including selective serotonin reuptake inhibitors (SSRIs).
Study Design and Results
The Phase 2 study randomized 36 patients in a 2-to-1 ratio to receive either 20 mg of HLP004 or a 2 mg dose, administered intramuscularly in two doses three weeks apart. Participants were followed for 12 weeks, with continued observational follow-up extending up to one year. All participants continued to receive their existing standard-of-care medications for GAD throughout the trial.
Patients receiving 20mg HLP004 in addition to standard therapy achieved a mean reduction of 10.4 points in the Hamilton Anxiety Rating Scale (HAM-A) from baseline at six weeks. The study population had an average baseline HAM-A score of 22 and a General Anxiety Disorder-7 (GAD-7) score of 10 or greater at screening. The 10-point improvement in anxiety symptoms is in addition to the benefits already seen with standard treatment.
the study group demonstrated a 67% response rate and a 39% recovery rate after six months. Those assigned to the 20 mg dosage group showed a 59% response and recovery rate at week six, while the 2 mg group achieved a 30% rate at the same time point. The treatment period was short, with acute drug effects lasting approximately 90 minutes and patients being ready for discharge within three hours, aligning with existing interventional psychiatry clinic protocols.
Safety and Tolerability
The study indicated a favorable safety profile, with no serious drug-related adverse events or safety signals related to suicidal ideation reported.
Company Statement
“Patients suffering from generalized anxiety disorder remain significantly underserved, with many continuing to struggle despite currently available treatments,” said Michael Cola, CEO of Helus Pharma. “We are inspired by these data and the potential of HLP004 to bring hope to patients with ORT. Our broad portfolio of intellectual property has once again been leveraged to create what we believe are best-in-class products, and we appear forward to releasing data on HLP003 targeting major depressive disorder in the fourth quarter of 2026.”
Other Developments in Psychedelic Research
Recent developments in the field include AtaiBeckley (ATAI) receiving FDA support for the Phase 3 design of BPL-003, a treatment for treatment-resistant depression, and Clearmind Medicine (CMND) receiving a recommendation from its Data and Safety Monitoring Board to continue its Phase I/IIa clinical trial for CMND-100 in treating alcohol use disorder. GH Research (GHRS) also reported Q4 earnings and is seeking FDA approval for its Phase 3 program for GH001 in treatment-resistant depression.
PharmAla Biotech Holdings (MDXXF) has entered into a supply and data agreement with Nautilus Sanctuary to supply MDMA for a Phase 2 clinical trial for PTSD in first responders, and Psyence Biomedical (PBM) has exported its GMP-compliant psilocybin product NPX-5 to Australia for a Phase 2 clinical trial in cancer patients with adjustment disorders.