GH Research leaps on psychedelic data in depression

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Dr Villy Valcheva, CEO of Dublin, Ireland-based GH Research
GH Research

Dr Villy Valcheva, CEO of Dublin, Ireland-based GH Research

GH Research's inhaled psychedelic therapy GH001 has shown promise in a mid-stage trial in treatment-resistant depression (TRD), sending its shares soaring and prompting a $150 million offering to raise funds for further trials.

The phase 2b study met its primary objective, with GH001 achieving an "ultra-rapid" treatment effect compared to placebo on the Montgomery-Åsberg Depression Rating Scale (MADRS), according to the Dublin, Ireland-based company.

GH001 – also known as mebufotenin – is an inhaled formulation of 5-MeO-DMT, based on a hallucinogenic substance secreted by a species of toad (Bufo alvarius) that has attracted a lot of attention for its potential in hard-to-treat mental health disorders like depression and post-traumatic stress disorder (PTSD).

GH's trial involved 81 patients with TRD who were treated with GH001 or a placebo, without the accompanying psychotherapy that has been used in other trials of psychedelics, like psilocybin derivatives.

GH001 achieved a statistically significant reduction from baseline of 15.2 points in MADRS total score on day 8, compared with a 0.3-point increase with placebo, giving a difference of 15.5 points between the groups, which was highly statistically significant.

That was backed up by significant improvements in secondary endpoints, including assessments of symptoms like anxiety and patient-reported quality-of-life, according to the company, which saw its Nasdaq-listed shares rise more than two-thirds on the back of the announcement.

Moreover, there was evidence of a benefit with the psychedelic at two hours and two days after dosing, while almost 78% of patients treated with GH001 were in remission from their depression at six months, according to data from an open-label extension to the study.

The result injects some welcome positive news into the emerging psychedelics category after the FDA's rejection last September of Lykos Therapeutics' MDMA-based drug midomafetamine for PTSD over issues with the design of its main pivotal trial and delays to a readout of Compass Pathways' phase 3 programme for psilocybin-based COMP360 for TRD until the second quarter of this year.

On a conference call, GH's chief executive Dr Villy Valcheva pointed to a stronger improvement in MADRS at day 8 compared to Johnson & Johnson's pioneering intranasal ketamine-derived therapy Spravato (esketamine), which achieved a 4-point difference over control at that time point.

Spravato was approved in the US in 2019 as an add-on to antidepressant therapy in TRD patients and is on course for $1 billion-plus in sales this year. 

According to Valcheva, GH001 could offer a faster onset of action, a 75% reduction in administration visits, greater durability of response, and fewer restrictions on things like driving and operating machinery after patients are discharged.

The phase 2b data is "a significant milestone in our journey to interventional psychiatry," she said.