In an interview earlier this week, the Dales Report asked Psybio Therapeutics CEO and chairman Evan Levine what his company is focused on during a serious lull in the market.
“What’s important to us is intellectual property-based technology,” he said. The company has a portfolio of tryptamines that it has developed for use in the clinic, including seven that are currently at the patent-pending stage. Levine said Psybio has filed a new patent “approximately [once] every month” on its developing technology.
“We’ve also moved several products out of our laboratories into commercial scale manufacturing, with the intended use of going into human trials next year,” he added. The CEO said at this point in the game, “developing a portfolio for therapeutic use is the only thing that will eventually matter.”
What Differentiates Psybio?
Levine said what separates his company from other players in the game is its shying away from words like “psychedelic” and “psilocybin.” Another is its method for psilocybin synthesis: Psybio has developed a method of bacterial synthesis to produce psilocybin at scale, for which it is currently awaiting a patent.
“We can do it cheaper, faster, and greener than any other published method,” he said.
Psybio is developing these new novel formulations using genetically modified bacteria to create psychedelic compounds that simulate molecules found in psilocybin and may have the potential to increase their potency. TDR asked why Levine and the Psybio team believe creating designer psychedelic drugs is the way of the future.
“Psilocybin is becoming recognized as the prominent psychoactive compound within the magic mushroom, but there are other compounds within it that do offer psychotropic, therapeutic benefits,” he said. “We are essentially redesigning what exists in nature right now… and exploiting this innate synergy and rebalancing these different tryptamines.”
Where a magic mushroom might contain 2 percent psilocybin and far less than one percent of other tryptamines including norbaeocystinn, baeocystin, and aeruginascin, Psybio’s compounds contain different ratios that have resulted in “a more profound and efficacious signal in early-stage testing,” according to Levine.
Choosing the Right Partners + Executives
Psybio Therapeutics is working on these formulations with the contract research organization Albany Molecular Research Inc (AMRI). According to Levine, AMRI has plenty of experience in studying psychedelics.
“That’s why we chose them, but we chose them more importantly for their ability to work in bioreactors, and work with bacteria such as our product,” he said.
While some companies are focusing on the extraction of natural psilocybin, Levine suggested this method takes longer (mushrooms take six to eight weeks to grow) and is more costly.
“They’re highly variable in their compounds within, and it’s expensive to extract it,” he said. “As far as these other compounds, we don’t see anybody else working on them.”
In addition to its partnership with AMRI, the company announced last month that it would award a grant of $1.5 million to professors at the University of Miami “to expedite progress toward clinical trials of a portfolio of neuropsychiatric drugs.” According to Levine, researchers there will be studying four of the company’s metabolites, “rebalancing them, taking advantage of this innate synergy, and looking for different opportunities to improve therapeutics.”
In early April, the company appointed Dr. Michael Spigarelli as its chief medical officer. Spigarelli has spent decades in the medical industry and has worked on both clinical and regulatory strategies for new drugs.
“Aside from being a fantastic guy who has a tremendous amount of education and experience in the space, Michael is an MD [who] practiced medicine for 20 years,” said Levine. The clinical pharmacologist holds a PhD and has worked on thousands of trials in different capacities.
To listen to the rest of the interview, check out the video.