GH Research PLC (NASDAQ: GHRS) witnessed a substantial surge in its stock value today after announcing highly favorable results from a pivotal clinical trial. As of the latest pre-market update, GHRS shares had climbed by an impressive 88.40%, reaching $19.97.
Stock Performance and Investment Insights
The remarkable upswing follows the company’s disclosure that its primary endpoint was successfully met in a randomized, double-blind, placebo-controlled Phase 2b trial evaluating GH001, an inhalable mebufotenin therapy, for treatment-resistant depression (TRD). To further discuss these findings, GH Research is scheduled to hold a conference call and live webcast later today.
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Promising Results
81 individuals with a diagnosis of TRD were included in the Phase 2b study (GH001-TRD-201). Of them, GH001 was given to 40 patients and a placebo to 41. Crucially, the research design did not include psychotherapy therapies. The main outcome of the experiment showed a significant decline in Montgomery-Åsberg Depression Rating Scale (MADRS) scores. In sharp contrast to the 0.3-point gain seen in the placebo group, GH001 users showed an average drop of 15.2 points from baseline on Day 8.
Secondary endpoints also verified GH001’s effectiveness. GH001’s therapeutic promise in treating TRD was confirmed by statistically and clinically significant improvements on the Clinical Global Impression-Severity scale, the Hamilton Anxiety Rating Scale, and the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form.
Ongoing Observations and Future Prospects
As of January 22, 2025, nine patients remain in the open-label extension (OLE) phase, while 54 have completed the study and 18 have exited prematurely. Among OLE completers, 77.8% achieved remission by the six-month mark, with 63% requiring only one to four GH001 treatments within this period. While the OLE safety analysis is still underway, no serious adverse events have been reported thus far.
These groundbreaking Phase 2b findings underscore GH Research’s pivotal role in advancing interventional psychiatry. With GH001’s potential to redefine TRD treatment through rapid and sustained symptom relief, the company is poised for significant commercial success and broader clinical adoption.