GH Research Primary Endpoint Met in Phase 2b Depression Trial

 

• Primary endpoint met, GH001 led to an ultra-rapid anti-depressant effect with a significant placebo-adjusted MADRS reduction from baseline of -15.5 on Day 8 (p<0.0001)
• The majority of the patients treated with GH001 achieved remission with a 57.5% remission rate on Day 8 compared with 0% in the placebo group (p<0.0001)
• All other secondary endpoints were met with clinically and statistically significant improvements on Day 8, compared with placebo
• During the double-blind part, GH001 was well tolerated and no serious adverse events (SAE) were reported. There was no evidence of treatment-emergent suicidal ideation or behavior. As of January 22, 2025, no SAEs have been reported throughout the open label extension (OLE)
• As of January 22, 2025, 77.8% of the OLE completers were in remission at the 6-month visit, with infrequent treatments
• Patients who had remission on Day 8 after their first active treatment had a 91.7% remission rate at 6 months

https://www.globenewswire.com/news-release/2025/02/03/3019385/0/en/GH-Research-Announces-Primary-Endpoint-Met-in-Phase-2b-Trial-with-GH001-in-TRD-Demonstrating-15-5-Point-Placebo-adjusted-MADRS-Reduction.html