Helus HLP004 Phase 2 Posts 10.4-Point HAM-A Gain; BPL-003 Phase 3 Wins FDA Nod
Helus Pharma’s Phase 2 HLP004 trial in moderate-to-severe GAD showed a 10.4-point mean HAM-A reduction at six weeks, 67% responders and 39% remitters with no serious drug-related adverse events. AtaiBeckley received FDA support for its BPL-003 Phase 3 program, Clearmind’s DSMB endorsed CMND-100 continuation and GH Research reported a $0.79 FY25 loss.
1. Helus Pharma Phase 2 HLP004 Signal Detection Study
In a 36-patient, 2:1 randomized trial, moderate-to-severe GAD patients on standard antidepressant therapy received 20 mg or 2 mg HLP004. At six weeks the 20 mg arm achieved a 10.4-point mean HAM-A drop, with 59% responders and 32% remitters; pooled data at six months showed 67% response and 39% remission. The drug produced acute effects lasting ~90 minutes, discharge readiness within ~3 hours and no serious drug-related adverse events.
2. AtaiBeckley FDA End-of-Phase 2 Meeting for BPL-003
AtaiBeckley secured FDA agreement on its pivotal Phase 3 design for intranasal BPL-003 in treatment-resistant depression. The pivotal program comprises two parallel trials—ReConnection 1 (≈350 patients, single-dose arms at 8 mg, 4 mg, placebo) and ReConnection 2 (≈300 patients, two-dose induction model)—each featuring a 12-week placebo-controlled core and 52-week open-label extension.
3. Clearmind DSMB Recommends CMND-100 Trial Continuation
Clearmind’s independent Data and Safety Monitoring Board reviewed top-line safety data from the second cohort of its Phase I/IIa CMND-100 trial in Alcohol Use Disorder and unanimously recommended progression to the third cohort. The higher-dose second cohort showed no serious adverse events or suicidality signals, supporting an 80 mg dosing in the next cohort.
4. GH Research Q4 FY25 Earnings and Cash Position
GH Research reported a FY25 loss of $0.79 per share versus a consensus loss of $0.82 and ended the period with $XX million in cash, cash equivalents and marketable securities. Management projects that existing resources will fund operations into the third quarter of 2027 at current burn rates.