Compass Pathways recently released results from a phase 2b trial, which was focused on evaluating the effectiveness of psilocybin as a treatment for depression. The results, which were announced earlier last week, show that the psychedelic substance was highly effective as a treatment for treatment-resistant depression.
For their study, the researchers recruited more than 200 sites in different locations in North America and Europe. This study was the largest double-blind randomized controlled trial on psilocybin, which is an active compound found in hallucinogenic mushrooms.
The company stated that it observed a significant reduction in symptoms of depression in patients who received a psilocybin dose of 25mg. This is in comparison to those who received a 1mg dose of psilocybin. The researchers also found that roughly 29% of patients who received the high dose were in remission three weeks after the treatment had been administered. The patients in this group also experienced an average decrease on the Montgomery-Asberg Depression Rating Scale, which is a measure of clinical depression.
The researchers also observed some side effects from the participants, which included self-injury and suicidal ideation. In a call with investors, the company’s chief medical officer, Guy Goodwin, stated that the suicidal behaviors were observed about a month after the treatment had been administered, noting that it was only in one patient that suicidal behavior was observed in the early stages of treatment.
Compass Pathways president and cofounder Lars Christian Wilde stated that the company was very happy with the trial’s results because this was a first in research on depression.
Stanford neuroscience researcher Boris Heifets, who wasn’t part of the study, asserted that the trial’s findings were promising. Heifets, who studies psychedelic substances, noted that psilocybin’s efficacy at three weeks was comparable to the effects of ketamine, which had been observed in a prior study, suggesting that the psychedelic’s benefits held up well over time.
The FDA recently granted Compass Pathway’s treatment a breakthrough designation, which means that the process to get the drug approved would be hastened if research continues to demonstrate positive results. The company plans to conduct a phase 3 trial in 2022, with the latest results suggesting that it may use a 25mg psilocybin dose. However, Wilde notes that decisions for the trial will be made after conversations with relevant regulators.
It should be noted that the results of this trial haven’t been peer reviewed nor have they been reported in a medical journal.
The positive outcome of this clinical trial comes as no surprise since the medicinal potential of several psychedelic compounds has been known for quite some time, and many companies, including Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF), are conducting R&D to bring more formulations containing psychedelics to market.
NOTE TO INVESTORS: The latest news and updates relating to Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF) are available in the company’s newsroom at https://ibn.fm/MYCOF
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