CEO Rob Tessarolo Explains NeonMind Reorganization and Goals With FDA

This past week, NeonMind Biosciences Inc (CNSX: NEON) (OTCMKTS: NMDBF) announced a strategic reorganization of its pharmaceutical division, among other corporate news. This reorganization at NeonMind plans to help focus and advance their leading drug candidate, NEO-001, through the regulatory process in plans to be used to target obesity and chronic weight management.

We’ve spoken with CEO Rob Tessarolo in months past about how NeonMind plans to use psilocybin to treat obesity, and we’re pleased to welcome him back to this episode of The Dales report to discuss updates and what the reorg means for NeonMind Bioscience’s plans.

Here’s some highlights from the interview:

2021 has been a year of planning that will see NeonMind advance its programs in obesity

Tessarolo says that he believes NeonMind will be the first to have a regulatory-approved psychedelic modality for obesity, and that a number of months in 2021 has been devoted to “making what we think is an efficient and clear plan to advance our programs in the obesity realm.”

He adds that for the company, this means getting to the FDA for consultation, sharing NeonMind’s plans, and having them endorse the plan for investigating high-dose psilocybin for chronic weight management in obese patients. Getting some positive feedback from the FDA means that they might be able to launch a human study in early 2022.

NeonMind also plans to consult with Health Canada later this year.

NeonMind Reorganization brings professionals with extensive regulatory experience

Tessarolo says that it was “essential” that NeonMind bring in individuals and biotech professionals who had “extensive regulatory experience.”

“These are high stake interactions. We need to put our best foot forward,” Tessarolo says of the anticipated consultations with the FDA. He goes on to explain that guidance the FDA has put out in the past is constantly evolving, so when seeking consultation, it’s important to be prepared.

As part of NeonMind reorganization, Philippe Martin has been appointed chairman of R&D advisory board

Philippe Martin’s addition to the team is part of a strategy of “execution” Tessarolo explains. To create value for investors as a relatively new public issuer, advancing a research idea requires clear and concise plans on how to rapidly and responsibly get through the regulatory events required for any substance’s commercialization and the ability to execute the plan in a reliable way.

Martin has expertise across a variety of therapeutic categories, says Tessarolo. Martin is currently also head of R&D for an oncology department out in San Diego. So, he is well-versed in regulatory process and program development, with a good understanding of what is required to work with the FDA.

Tessarolo explains that a positive pre-IND meeting with the FDA is a material event for a company like NeonMind, and the company is already working ahead on Phase 1 and 2 studies will look like if allowed to move forward. “When we’re allowed to go, we can go, and go efficiently and effectively,” he says.

NEO-001 and 002 both target appetite

NeonMind’s currently got two programs: NEO-001 and NEO-002. Tessarolo explains that neural plasticity, mindfulness, and the reset of the brain’s default mode network is what will be targeted with 001. NEO-001 is described as a higher dose of psilocybin “with supportive and wraparound psychotherapy.”

002 will be a supplemental program, a low-dose of psilocybin that Tessarolo says will not hit the 5-HT2A receptors or produce hallucinogenic experiences or effects. The downside to lower-doses mean that 002 will have to be administered on a regular basis, which will make it “a laggard program” due to an extra level of data and safety characterization required.

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