Psychedelic Medicine: 5-MeO-DMT Formula For Treatment-Resistant Depression Has Positive Trial Results

Clinical-stage biopharmaceutical company GH Research PLC GHRS announced positive results from recent clinical trials of its leading 5-MeO-DMT formula, a therapy candidate for patients suffering from treatment-resistant depression (TRD).

The Ireland-based company, which this year announced a capital raise of $315 million, is focused exclusively on research around the psychoactive molecule 5-MeO-DMT to treat depression, a condition that affects many millions of people around the world. Currently, an estimated 50 percent of patients receiving therapy for TRD do not respond to approved depression medications.

The lack of effective treatments for TRD has created a market for companies like GH Research seeking to develop such therapies, potentially changing the way TRD is treated today. So far, GH Research is on track to validate claims that their proprietary GH001 5-MeO-DMT formula is safe and could provide relief from TRD with no serious adverse events for patients.

Completing two Phase 1 healthy-volunteer clinical trials and a Phase 1/2 clinical trial in patients with TRD, studies have so far revealed that 87.5% of patients were brought into an ultra-rapid remission after an individualized single-day dosing regimen using GH Research’s inhalable 5-MeO-DMT product.

Fast action the key: Part of what makes the substance valuable for clinicians treating depression is the drug’s potency and fast-acting nature, with onset occurring within seconds and treatments lasting on average a relatively rapid 15 to 20 minutes. Shorter duration psychedelic treatments will likely scale better than other psychedelic treatments, such as therapies using psilocybin or MDMA, which can require five to eight hours from clinicians involved in administering and monitoring patients.

Biopharmaceutical companies are keenly aware of creating therapies that require less time and fewer clinician hours in the hopes of health insurance providers covering treatments, as is the case with ketamine treatments.

Another key action of 5-MeO-DMT is its ability to produce ego loss or “ego death” during an experience using the drug, which can produce valuable insights that change one’s overall perception of life and its difficulties.

Making news headlines over the last month was heavyweight fighter Mike Tyson’s endorsement of the substance as a positive catalyst that transformed his life.

“I ‘died’ during my first trip,” Tyson said. “In my trips, I’ve seen that death is beautiful. Life and death both have to be beautiful, but death has a bad rep.”

Found naturally in small 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 exploration in the psychedelic underground since the 1980s.

The substance has made its way over the past decade into labs like GH Research, with the mounting use of synthetic forms of 5-MeO-DMT employed to study potential therapies for TRD.

One important study in 2019, which garnered interest in the drug and its use for depression, 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.” 

GH Research has plans to request an initial investigational new drug (IND) meeting with the FDA in the first quarter of 2022, reported Green Market Report.

An IND approval from the FDA would provide the drugmaker authority to proceed to the next stage of trials if the experimental drugs are showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.

GH Research also stated that it has recently initiated development in two undisclosed psychiatric disorders which are expected to be announced in the first quarter of 2022.