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Shares of GH Research PLC GHRS have rallied 54.8% in a week after the company, on Feb. 3, 2025, announced that it has met the primary goal in a mid-stage study of its investigational, inhalable mebufotenin product candidate, GH001, to treat patients with treatment-resistant depression (TRD).
Per the data readout from the phase IIb TRD study, 40 patients treated with GH001 achieved a significant 15.2-point reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) score by Day 8, while the placebo group, comprising 41 patients, showed a slight increase of 0.3 points. Please note that MADRS is a metric showing the improvement of depressive symptoms in patients compared with placebo after the treatment period.
It was observed that most patients receiving GH001 achieved remission with a 57.5% remission rate on Day 8 compared with 0% in the placebo group. Furthermore, in the open-label extension (OLE) portion of the phase IIb study, TRD patients who had remission on Day 8 after their first dosage had a 91.7% remission rate at six months.
In the past three months, shares of GH Research have surged 74% against the industry’s 8.7% decline.
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Additionally, treatment with the candidate also met all secondary endpoints in the phase IIb study on Day 8 with clinically and statistically significant improvements on Day 8 compared with placebo.
For many TRD patients, existing therapies have proven ineffective, often leading to years of severe mental distress and significant impairment in daily life. Per GH Research, a novel treatment like GH001, offering a rapid and substantial effect, especially with the convenience of infrequent, short clinic visits lasting just 1-3 hours, has the potential to revolutionize clinical practice for the TRD indication.
GH Research reported that GH001 was well tolerated, with no serious adverse events reported on Day 8 of the phase IIb TRD study. All treatment-emergent adverse events were mild or moderate, with no severe events or reports of flashbacks. Safety analysis in the OLE portion of the mid-stage study is ongoing with no serious adverse events reported to date.
GHRS’ Ongoing Clinical Pipeline Development Programs
Apart from the TRD indication, GH Research is also currently evaluating GH001 for bipolar II disorder and postpartum depression in separate mid-stage proof-of-concept studies. Last month, the company reported meeting the primary endpoints of a significant reduction in MADRS total scores on Day 8 in both studies.
The company’s second mebufotenin product candidate, GH002, is currently undergoing early-stage development as an intravenous injection for treating psychiatric and neurological disorders.