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Investing.com -- Shares of GH Research PLC (NASDAQ:GHRS) surged 90% following the announcement that its Phase 2b trial for GH001, an inhalable treatment for treatment-resistant depression (TRD), met its primary endpoint. The company reported a significant placebo-adjusted reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) by -15.5 points on Day 8 of the trial.
The Dublin-based biopharmaceutical company unveiled the results today, highlighting the potential of GH001 as a transformative treatment for TRD. The trial demonstrated not only a rapid antidepressant effect but also a high remission rate among patients. On Day 8, 57.5% of patients treated with GH001 achieved remission, compared to none in the placebo group. In addition, all secondary endpoints showed clinically and statistically significant improvements.
Professor Michael E. Thase, MD, commented on the findings, "Patients treated with GH001 experienced a difference of -15.5 points in MADRS score at Day 8 compared to placebo, which is truly remarkable. Most TRD patients have not benefited from a number of established treatment options and this illness frequently imposes years of insurmountable mental suffering and disabling effects on social and vocational functioning. A novel treatment with such a large and rapid effect, particularly one that may require only infrequent, short 1-3 hours clinic visits, has the potential to be a practice changing treatment.”
The safety profile of GH001 was also favorable, with no serious adverse events reported during the double-blind portion of the trial. The treatment was well tolerated, with the majority of patients being discharge-ready within an hour of their last dose, and no evidence of treatment-emergent suicidal ideation or behavior.
As of January 22, 2025, a majority of the patients who completed the open label extension (OLE) of the trial were still in remission at the six-month mark, with 77.8% achieving this status. The OLE is ongoing, but no serious adverse events have been reported to date.
Dr. Villy Valcheva, CEO of GH Research, expressed optimism about the trial’s results, stating, "Today, as we share our unprecedented positive Phase 2b data, we celebrate a significant milestone in our journey to interventional psychiatry and pave the way for our future commercial success with GH001 in treatment-resistant depression."
Investors have responded positively to these results, propelling GH Research stock upwards as the company continues to develop GH001, which could potentially offer a new standard of care for patients suffering from TRD.
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