Setting up to manufacture synthetic psychedelics is fairly expensive. Unsurprisingly, many companies in the space have opted to put their money, so to speak, on one or two horses as a result. PharmAla Biotech is a new Canadian psychedelics manufacturing company. Their focus is manufacturing MDMA and other MDXX substances. We’re thrilled to have the CEO of PharmAla, Nick Kadysh, with us on this episode of The Dales Report.
Here’s some highlights from the interview.
Kadysh had a strong background in running regulatory departments for large corporations before he launched PharmAla
From a start in the provincial government, Kadysh moved on to spend a decade in the thick of PR and GR for companies like Red Bull, GE, and Juul Labs. His interest in the psychedelics industry began after he joined the board for Psyched Wellness. That, he says, is where he “went down the rabbit hole.”
PharmAla Biotech’s focus and how Kadysh feels they bring a unique proposition
Just last year, Kadysh launched PharmAla Biotech, a B2B business that will be focused on manufacturing MDMA and analogues. PharmAla will also be developing some novel approaches to forming these compounds.
“Regulators look at medicine through two lenses: efficacy and safety,” Kadysh says. “And I think most companies in the space are focused on efficacy, right? Proving that the molecule does what they think it does. … We’re actually focused on the safety side. So, I think we’re a little different in that respect.”
PharmAla was built to take on a molecule Kadysh admits that he’s been interested in for a long time. “I always thought it had great clinical potential,” he says. And he also believes that neither the industry nor the public are ready to consider recreational use.
“I am on record in saying that at this time I don’t think we have the data to prove that these molecules are appropriate for a recreational market,” he says. “But my background is regulatory. I’ve been a huge harm-reduction advocate for a very long time. Like I don’t think that these molecules should have ever been made illegal. That was totally off base. So, what we are left with is medicine. Functionally, these are therapeutic molecules. They shouldn’t be illegal, they shouldn’t be recreational, they should be regulated as medicine.”
But what might be the most interesting part is that he appears to be fairly confident that the toxicity of MDMA and other molecules in its class can be reduced. This is based on some preclinical data. While it is true to an extent that “the dose makes the poison,” he admits that there is also truth in that MDMA is associated with claims about hypothermia and neurotoxicity.
To make the product more available for treatments, he says, you have to address objective toxicological truth. Also involved is addressing people’s view of the drug. So, PharmAla’s focus on safety addresses both levels, Kadysh says.
Investors “more sophisticated” says Kadysh
PharmAla Biotech has just gone through its first round of fundraising, which Kadysh considers to have been very successful. One of the things that most impressed him in this round was the level of technical details that investors were interested in. “Sophistication has gone up,” he says.