Obesity Treatment
NeonMind Biosciences Inc., is on track to bring its psilocybin-based obesity treatment to the market. The company announced this week that its R&D Working Group has completed an integrated drug development plan for its experimental psychedelic, NEO-001, a high-dose psilocybin treatment intended to be used alongside behavior therapy and lifestyle intervention to treat obesity.
As part of its regulatory strategy, the company is planning a Pre-Investigational New Drug meeting with the U.S. Food and Drug Administration (FDA) as well as a Pre-Clinical Trial Application Consultation with Health Canada. Both meetings are expected to occur before the end of the year. The company anticipates a Phase 1/2 proof-of-concept study in obese participants during the first half of 2022.
“Growing evidence supports the therapeutic promise of psilocybin as a psychiatric tool that can help facilitate cognitive flexibility and behavioral plasticity,” says Dr. Albert Garcia-Romeu, assistant professor of psychiatry and behavioral sciences at the Johns Hopkins Center for Psychedelic & Consciousness Research and advisor to NeonMind. “Recent clinical and neuroimaging data suggest persisting changes in patterns of brain function after a single high dose of psilocybin, which are associated with enhanced mood and changes in emotional processing and anxiety. These shifts have been hypothesized to work as a sort of ‘mental reset’ that could have significant therapeutic potential for other health conditions like obesity.”
Clinical Research
Knowde Group Inc., a company specializing in cannabis and psychedelic research, entered a strategic partnership with LMC Manna Research. LMC has the largest network of fully owned and integrated clinical research sites in Canada providing phase 1-IV clinical trial services with a with a huge database of more than a million patients across the country. The partnership is in step with Knowde Group’s strategy of building a research organization focused on plant-based and progressive medicine including psychedelics, natural health products, and supplements.
“We don’t want to see research fall to the wayside as it has for cannabis, both in Canada and globally. We are in a mental health crisis and its critical to ensure that we conduct clinical trials to demonstrate safety, and efficacy up to and including phase 3 large scale clinical trials,” says Knowde Group’s COO Sabrina Ramkellawan. “Knowde Group’s mandate is to provide full support to help with these efforts.”
Psychedelic research and development company Wake Network Inc., is teaming up with the Lieber Institute for Brain Development to develop a one-of-a-kind, genetics-based approach to psychedelic integration and clinical research on traumatic brain injury.
The “Wake Genomics Project” aims to develop a safety screening system to determine the most effective therapies for patients based on a combination of genome mapping, machine learning, and metabolic measurements.
“What we are seeing is a seismic shift in demand to explore psychedelic therapies. The most important area of focus for this emerging industry in order to be successful is risk mitigation at both the compound level, but also at the psychiatric level,” says Warren Needler, Wake’s president. “These compounds can cause profound shifts in consciousness, and certainly sometimes with adverse results. The work that Wake and the Lieber Institute are pursuing addresses this and allows for the industry to advance safely.”
Psychedelic Stock News
Cybin Inc., received conditional listing approval from the NYSE American LLC stock exchange, marking an important milestone for the psychedelic biotech firm. Provided the company meets all applicable regulatory requirements, it will list under the symbol “CYBN.” Cybin will maintain its current listing on the NEO Exchange.
“Conditional listing approval on the NYSE American is an important milestone in Cybin’s growth journey. We expect expanded access to investors to further fuel our mission to develop revolutionary psychedelic therapeutics for patients suffering from mental health conditions,” Cybin’s CEO Doug Drysdale says.
Additionally, Field Trip Health Ltd., a company focused on the development and delivery of psychedelic therapies, obtained conditional approval to list on NASDAQ. Upon final approval, the company focused on the development and delivery of psychedelic therapies will trade under the symbol “FTRP.” Final approval of the listing is subject to the company fulfilling any remaining conditions as required by NASDAQ. The Company expects to satisfy all of the requirements and will issue a statement once a trading date has been confirmed by NASDAQ.
“The anticipated listing of our stock on the NASDAQ is a key milestone in our evolution as a publicly-traded company,” said Joseph del Moral, Field Trip’s CEO. “We believe this anticipated listing will improve liquidity by enabling more investors to participate in our growth, and ultimately enhance long-term shareholder value.”
Mujeeb Jafferi, Field Trip’s COO added, “Psychedelics are experiencing a once-in-a-lifetime renaissance, as evidenced by the increasing support the industry is garnering from scientists, regulators and investors alike. We are proud to have established a leadership position in the industry at this exciting time and remain laser-focused on our drug development program advancing work on FT-104, our next generation psychedelic molecule, and the continued rollout of our Field Trip Health clinics business, which is bringing much-needed psychedelic therapies to those in need.”
