Taking Magic Mushrooms Towards Phase 3 Trials

Psilocybin has been studied in the past but the research has stopped, academic centers have helped to resurrect interest in more recent years, overcoming constraints on the study of the molecule to generate evidence of its effectiveness in hard to treat patients. 

Following the reopened path the company has raised #31 million in a series A round and generated data from healthy volunteers on the safety of psilocybin therapy. Compass has raised money for the next steps in the process with the end of a phase 2b near. The series B will allow the company to run several trials that will help to design the phase 3, and through these studies the company hopes to gain better understandings of how psilocybin interacts with selective serotonin reuptake inhibitors and other drugs to have a clearer idea of the roles therapy with psilocybin could have. 

George Goldsmith, CEO and Co-founder, COMPASS Pathways, said, "Too many people are suffering with treatment resistant depression. We are committed to developing innovations, such as psilocybin therapy, to address this rapidly growing problem. Patents help ensure sustainable funding to conduct the highest quality clinical research to bring the best new therapies to patients who urgently need them. If this research demonstrates psilocybin therapy is a safe and effective option for patients, we will price it responsibly with the goal of making it as affordable and accessible as possible."

Currently psilocybin is listed as being a Schedule 1 controlled drug and as such it is subject to restrictions. Having managed to navigate through various issues regarding the drug to get it to its sites the company doesn’t expect to have those same difficulties moving into phase 3, the knowledge and resources obtained during the phase 2B will be utilized to help ease the transition into the larger study. 

“We actually have over 20 sites that all recruit very well. We're well positioned to recycle those sites for our phase 3 program. The only other challenge is to train therapists in the treatment modality. That has gone very well to date. We have trained over 70 therapists. That shouldn't be a hurdle to scaling up the trials,” says Compass co-founder Lars Wilde president and chief business officer of Compass.

The series B will also support work to improve the therapist training program ahead of the phase 3. Preparations for the phase 3 are continuing around current lockdowns, but some of the partners stopped activities and caused the biotech to halt participant enrollment into the study which was hoped to have been completed by the end of 2020.

“It's a bit unfortunate because the study was going extremely well in terms of recruitment, but the good thing is we have an amazing backlog of patients waiting to be enrolled into the study who have been prescreened already. As soon as the world opens up again, we'll be ready to go and resume the activities in the 2b program,” Wilde said. 

The company is advancing the clinical program while working on earlier stage projects that initially focus on psilocybin therapy for those with treatment resistant depression. "While psilocybin is a great starting point … we think that based on the learnings that we have generated in our preclinical and mechanistic work we will be able to develop even better medications,” Wilde said.

The company has partners with several academic centers which are primarily in American to form a virtual drug discovery center that is focused on finding and advancing better medications. Compass will be using some of the series B funds to invest into its increasing the size of its London based preclinical teams that are coordinating the drug discovery work with the American teams.