In a webinar yesterday hosted by Jos Schmitt, President and CEO of the NEO Exchange, Cybin Inc. CEO Doug Drysdale announced Cybin’s partnership with global clinical research organization Veristat, along with several other developments in Cybin’s research and development pipeline surrounding sublingual psilocybin film.
Doug Drysdale on the Timeline for Cybin’s Psychedelic Drug Development
Schmitt raised the key point that, while there is a tremendous level of excitement around psychedelics, the real outcome will be to bring these products to market. “Where are you today,” he asked? “When is this going to be real and accessible?”
“Perhaps faster than you think,” answered Drysdale. “We have a number of programs we could talk about but our lead program that I’ll talk about first is our Phase II study, for which preparation is underway right now. I’m happy to announce today that we’ve partnered with Veristat, a global clinical research organization. They’ve been responsible for thousands of studies around the world, and they’ll be supporting our study in terms of data management and biostatistics, making sure it’s compliant, and maintaining that data integrity. We’ll be studying our sublingual formulation in 160 patients with major depressive disorder.”
Drysdale went on to say that dose selection and the collection of initial efficacy data for this trial would likely be completed by the end of the first quarter of next year, with the remainder of Phase II following by the end of 2021. “I’ll say that this is about one year faster than our competition. What that means is that we expect to start applying for marketing approvals by early 2022. We could potentially have the first approved psilocybin treatment for depression on the global market pretty quickly.”
“All the Work Being Done in the Space is Very Important”
Moving on, Schmitt asked “What do investors need to know about you that makes you different?”
“First off, let me just say that all the work being done in the space is very important. The progress that companies like COMPASS Pathways and MinMed are making is good for patients, is good for the science, and it helps progress the treatments to market and help people in need. If you’re looking for comparisons, COMPASS is also developing a psilocybin oral capsule, where we’re developing a sublingual film that gives us an advantage in terms of being faster in terms of onset.”
Drysdale went on to say “We recently closed an oversubscribed financing round, so we’re well capitalized, which is always good but particularly in these uncertain times. It also gives us a substantial war chest for M&A (mergers and acquisitions). We have a very active M&A pipeline, and the near term focus of our M&A activity will be adding novel molecules and diversifying our portfolio. Adding to psilocybin, bringing in new IP, and new indications. We’re looking at second-generation psychedelic compounds with improved treatment profiles, talking about properties like shorter duration of action, a smoother pharmacokinetic profile, meaning fewer side-effects, and more scalable treatment. We think that adding these types of assets adds a lot of value to Cybin, and for shareholders.”
“In the near future, we can see expanding our discovery and development capabilities through acquisitions, adding scientific depth to the business. We’re working on a number of collaborations with private companies and partnerships with research institutions, potentially adding new clinical programs and novel supported deliveries. We have a pretty active couple of months ahead of us.”
Truffle Report wishes to disclose that Cybin Inc. is a client of our parent company, Puff Digital. The content of this article was not solicited or sponsored in any way.
Further, the author of this piece wishes to disclose that he owns shares of Cybin Inc.