GH Research Goes Public To Turn 5-MeO-DMT Into Medicine For Treatment-Resistant Depression

The substance 5-MeO-DMT, often referred to as the most potent psychoactive drug on earth, is now making its way from the capable hands of psychedelic pioneers — who for decades have demonstrated its psychotherapeutic effectiveness — into the glossy white laboratories of multimillion-dollar corporate research labs.

Existing naturally in limited quantities in some plants, 5-MeO-DMT is most notably found in higher concentrations in the dried venom of the Bufo alvarius toad, also known as the Sonoran Desert toad. The amphibian’s defense secretions have been the source of mounting psychedelic exploration in the underground since the 1980s, when Army vet and independent researcher Ken Nelson (believed to be the first person to have ever sampled toad venom) wrote the iconic booklet Bufo Alvarius: The Psychedelic Toad of the Sonoran Desert.

Effects from vaporizing 5-MeO-DMT — whether toad-derived or lab-made — often include onset within seconds and mind-altering, boundless experiences that last 15-20 minutes. It has been called the “God molecule” for its ability to launch users into a transcendent state. One leading study in 2019 of 5-MeO-DMT showed that participants who experienced high levels of “ego dissolution or oceanic boundlessness during their session displayed higher ratings of satisfaction with life and lower ratings of depression and stress.”

That’s what Ireland-based GH Research PLC is after with their formulation of 5-MeO-DMT, dubbed “GH001”: Tackling the crippling symptoms of chronic depression. Specifically, the group is focusing on developing novel and proprietary 5-MeO-DMT therapies for people with treatment-resistant depression. Announcing completion of a Phase 1 clinical study in healthy volunteers late last year, which showed the drug was safe and well-tolerated via inhalation at investigated dose levels, last week GH Research made its public debut on Nasdaq (GHRS) hitting a high of $24.19, well over its IPO price of $16 per share.

A prospectus filed by GH Research to the Securities and Exchange Commission (SEC) on June 21 notes that 5-MeO-DMT is currently classified as a Schedule I drug in the U.S. and any product containing the substance must be rescheduled by the federal government to be marketed. It also describes the challenges inherent to bringing a new drug therapy to market, including demonstrating acceptable safety profiles and gaining regulatory approval. There’s also the issue of having a viable plan in place to scale up implementation of care for patients. The latter is one of the key issues that biopharma companies face when creating psychedelic-assisted therapy models. Particularly the challenge of deploying enough practitioners to provide care to patients.

Another European frontrunner making moves this year developing therapies using 5-MeO-DMT is U.K.-based Beckley Psytech, a strategic partner of the Beckley Foundation created by psychedelic maverick Lady Amanda Feilding. Her organization has for over 20 years focused on scientific research into psychedelic medicines. Among other psychedelic-based therapies the company is developing, Beckley Psytech sees 5-MeO-DMT as a potential medicine that could have a significant positive impact on patients suffering from treatment-resistant depression. CEO and founder of Beckley Psytech Cosmo Feilding Mellen commented in April that the company would be breaking new ground this year on a clinical study of intranasal 5-MeO-DMT, conducting an initial Phase 1 trial with 42 participants. They appear to be ahead of the curve on plans for scaling delivery of therapies. Teaming up this year with U.S. group Fluence — an organization focused on psychedelic education and training of mental health providers in psychedelic treatments — the duo has plans to produce the first 5-MeO-DMT psychedelic training program. Their aim is to develop a program with Fluence that will enable therapists to work with patients remotely, leveraging digital technologies to improve patient treatment and care, and reduce utilization of healthcare resources.

While GH Research has been quiet in the press during their IPO period for compliance reasons, Florian Schönharting, Chairman of the Board of Directors of GH Research, said in a press release that the company is “executing an accelerated clinical development program with GH001 in patients with treatment-resistant depression. GH001 has the potential to establish a new paradigm in the treatment of a range of mental diseases," he said.

The formulation is currently being investigated in the Phase 2 part of an ongoing Phase 1/2 clinical trial in patients with treatment-resistant depression.