Why Is GH Research Stock Trading Higher On Monday?

On Monday, GH Research PLC GHRS said its Phase 2b trial with GH001, an inhalable bufotenin product candidate for treatment-resistant depression, met its primary endpoint.

The trial recruited 81 patients. In the double-blind part, 40 patients received GH001 and 41 received placebo. Psychotherapeutic intervention was not a component of either part of this trial.

GH001 led to a significant reduction from baseline of -15.2 points in Montgomery-Åsberg Depression Rating Scale (MADRS) total score on Day 8, compared with +0.3 points in the placebo group (difference of -15.5 points, p<0.0001).

All secondary endpoints in the trial were met, with results consistent with the primary endpoint.

Treatment with GH001 led to clinically and statistically significant improvements on the CGI-S and HAM-A scales and the Q-LES-Q-SF Questionnaire on Day 8, compared with placebo.

GH001 was well tolerated, and no serious adverse events were reported. All treatment-emergent adverse events (TEAEs) were mild or moderate, with no severe adverse events observed. No TEAEs of flashbacks were reported.

As of Jan. 22, nine patients are ongoing, 54 patients have completed, and 18 patients have discontinued early (with one discontinuation due to an adverse event).

Of the OLE completers, 77.8% were in remission (MADRS≤10) at the 6-month visit. Most OLE completers (63.0%) received 1-4 GH001 treatments for the 6 months.

Safety analysis has not yet been completed for the OLE as it remains ongoing, but as of Jan. 22, no serious adverse events have been reported throughout the OLE.

Price Action: GHRS stock is up 74% at $18.48 at last check Monday.

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