EXCLUSIVE: In Reinventing Mental Health & Next-Gen Psychedelics, 'Access And Clinical Data Are Key'

Experts gathered at the Benzinga Psychedelics Capital Conference in Miami Beach on Thursday where they talked about revolutionizing psychedelic therapy as a promising new approach for treating mental health conditions and how clinical data is crucial to pulling institutional investors into the industry.

Revolutionizing Psychedelic Therapy: Safer And More Tolerable Treatment 

"The future of psychedelics may lie in developing non-hallucinogenic versions that can provide therapeutic benefits without the risks associated with traditional psychedelic drugs," said Evan Levine, CEO & chairman at PsyBio Therapeutics Corp PSYBF, who is studying 18 different molecules with unique therapeutic properties.

Joseph Tucker, CEO at Enveric Biosciences Inc ENVB agreed, adding that's 

the promise of the next-gen, "when we're able to remove the hallucinogenic experience [and] when we're able to remove the requirement for two healthcare practitioners and eight hours sessions." 

Jim Gilligan, CEO & CSO at Tryp Therapeutics Inc TRYPF said they are exploring the medical potential of psilocybin and considering other areas where it may have therapeutic benefits. “We are looking at administering psilocybin through IV, which is a more accurate and user-friendly method of drug delivery," Gilligan added.

The importance of access and protection of traditional uses: "As a company, it's crucial to provide rare and high-demand psychedelics to indigenous communities (...) especially when it comes to the different regulations and access to peyote in Canada versus the United States," said Claire Stawnyczy, CEO at Lophos Pharmaceuticals Corp., who also expressed particular interest in Maps' work on mescaline and the similarity between mescaline and MDMA.

Regulation, Education & More

The panel's moderator Anne Donohoe, managing director at KCSA, stressed the need for education and engagement with regulators and legislators to overcome regulatory challenges in the US and Canada.

"The only pathway we can really rely on to eventually operate access is by going through the healthcare regulatory bodies such as FDA and Health Canada (...) but we have another barrier, the DEA," Levine said.

"Interestingly, when we introduce a novel compound to regulators, they do not initially recognize it as a psychedelic substance,” Tucker said. However, “if any of our compounds are found to be contaminated or contain an unknown psychedelic agent, we would encounter similar challenges.”

According to Gilligan, "There is still a lot of work to be done in terms of conducting more clinical studies to gather more data.”

Although Peyote regulation in Canada is exempt from Schedule III, "We have faced challenges in obtaining licensing for studying it," said Stawnyczy, who is still eagerly awaiting its approval. "Our ultimate goal is to conduct clinical trials in the United States, and we understand that working closely with regulators is key to achieving that goal."

Getting Institutional Investors Involved In The Biotech Market

In 2020, “PsyBio Therapeutics went public on NASDAQ with significant demand from retail investors,” recalled Levine.

Three years later, "In the absence of capital, we need to find ways to generate meaningful clinical data to get this institutional investor to finally move into this market," said Tucker. “It’s important for biotech companies to be prepared to capitalize on opportunities as they emerge. You have to take the money when it's there.”

Gilligan agreed. “Data is the most important thing for credibility. It's all about eliminating risk and the more you can demonstrate safety and clinical utility you decrease the risk which then makes it more attractive to institutional investors."

Regarding the impact of recent market fluctuations on the biotech industry and trying to find a correlation with the cannabis industry, Levine said that while both industries have faced regulatory challenges, he sees the two as fundamentally different.

However, Tucker said that in the biotech industry, only companies with the best assets are likely to succeed and that investors should be prepared to choose carefully and accept that there will be both winners and losers.

It’s important to note that the global psychedelics drugs space is expected to grow at a 13.3% CAGR through 2029.

Photo by Kelsey Wilkerson