A small Ireland-based firm, GH Research, has announced positive results from a small trial it conducted to treat treatment-resistant depression. The results from this trial revealed that their inhalable version of mebufotenin was effective and fast in delivering clinically significant improvements in the patients selected for the study. Mebufotenin is molecularly similar to psilocybin and occurs in some psychedelic mushrooms. The shares of the company jumped nearly 100% upon the release of this news.
The results of the trial were released on Monday, Jan. 3 and the trial involved 81 participants. The subjects all suffered from treatment-resistant depression, and evaluations using a commonly used 60-point scale showed that the drug triggered at least a 15-point drop in the scale of depressive symptoms when compared to the study subjects that received a placebo.
The company said their formulation was well-tolerated by the study participants and that based on the reports received by Jan. 22, not a single serious adverse event had been brought to their attention by the subjects taking part in the trial. The reactions registered were moderate or mild, and no incidences of suicidal behavior or thoughts were registered. Heart activity also remained normal, and no participant reported experiencing flashbacks.
GH Research described their formulation as “ultra rapid” because it delivered relief within 8 days after the commencement of treatment. Within 8 days, 58 percent of the study participants were categorized as being in remission while none of those in the placebo group met the criteria for being categorized as being in remission.
The researchers conducted an “extension” phase of the study in which 54 of the original 81 participants received additional doses of the drug. This time, each subject knew they were receiving the psychedelic formulation. In this group of patients, 78 percent went into remission by the time six months elapsed from the commencement of the clinical trial.
Michael Thase, a University of Pennsylvania psychiatry professor serving as a scientific adviser to GH Research hailed the drug as a treatment option that had a rapid and large effect on patients. He added that it was particularly noteworthy that patients would only need to visit a facility for just 1-3 hours to get their treatment dose. Such a drug can change the way mental health treatment is administered, he added.
While these results are promising, the study involved a small number of patients and the results will need to be validated in other larger clinical trials before the needed regulatory approvals can be obtained for the drug to be commercialized. Other psychedelics startups like atai Life Sciences N.V. (NASDAQ: ATAI) will be following the work of GH Research and hoping that it results in advancing the commercialization of psychedelic medicines in different markets.
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