Recently, Compass Pathways (NASDAQ: CMPS) released new data on its COMP360 psilocybin therapy, which highlights that there’s no evidence suggesting that psilocybin gives rise to serious adverse events. The data also shows that the treatment could provide benefits beyond decreasing depressive symptoms in patients with depression.
The psychedelic company’s findings add to data released in November from its phase 2b clinical trial that tested the effectiveness of COMP360 in managing treatment-resistant depression. The trial, which is said to be the biggest psilocybin therapy trial carried out to date, compared two active doses of the therapy — 10 mg and 25 mg — with a 1mg dose.
The trial’s initial findings showed promised, with researchers observing that patients who received a 25 mg dose saw a reduction in symptoms of depression after three weeks, with roughly 24% of them sustaining this response 12 weeks after the drug’s administration.
However, the trial’s results were also met with a degree of disappointment as most of the participants experienced TEAEs (treatment-emergent adverse events). The researchers note that while 90% of them only had mild to moderate effects, the remainder experienced severe adverse events.
Dr. Guy Goodwin, Compass Pathways chief medical officer, stated that an analysis of this data offered more insights into the treatment’s safety as researchers found that the psilocybin therapy was well tolerated on a general scale. Goodwin also explained that comprehensive analysis of safety data supported the researchers’ conclusion, which found no evidence suggesting a causal relationship between the administration of the COMP360 psilocybin therapy and the severe adverse events of self-injury, suicidal behavior and suicidal ideation. He noted that the events were to be expected in this patient population and were known to occur unpredictably.
The newly released results show that patients who received the 25 mg dose experienced a significant improvement in measures of cognition, everyday functioning, quality of life, negative and positive affect, anxiety and self-reported depression when compared to those who received the 1 mg dose of the COMP360 therapy.
Dr. Sidney Zisook, the principal investigator of the trial, stated that most of the individuals who took part in the study had suffered from crippling and severe depressive disorders for years, despite various treatment trials with traditional antidepressant therapies and drugs.
The company is conducting a further analysis of its trial data. It plans to submit the trial’s complete data for publication in 2022. Compass Pathways maintains that its research objective is to find the appropriate dose for a larger phase 3 trial, which it hopes will start next year.
The outcomes of this trial add to the growing body of research done by companies such as Cybin Inc. (NYSE American: CYBN) (NEO: CYBN) that are looking to develop medicinal formulations from psychedelic compounds.
NOTE TO INVESTORS: The latest news and updates relating to Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) are available in the company’s newsroom at https://ibn.fm/CYBN
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