Mydecine Innovation Group reports positive meeting with US FDA for MYCO-001 smoking cessation study

Mydecine Innnovations Group Inc has announced a positive meeting with the US Food and Drug Administration (FDA) regarding its investigational new drug (IND) and breakthrough therapy status applications. The Denver-based biotech company reported a meeting with the FDA on February 28, 2022, to review its IND application to administer MYCO-001, in combination with therapy, to humans as part of smoking cessation treatment.  Leading drug and substance abuse researcher, Dr. Matthew Johnson of Johns Hopkins University, will serve as the lead investigator for this multi-site study, the company noted. “The data from Johns Hopkins University’s ongoing studies assessing psychedelic-assisted therapy to treat nicotine addiction is showing efficacy rates 2-3 times higher than the current gold standard of treatment,” said Mydecine chief medical officer Dr. Rakesh Jetly in a statement. “Our team is eager to start collecting the data needed to bring an approved drug product to market that could potentially save millions of lives.” READ: Mydecine Innovations announces inclusion of molecule with improved heart-safe microdose properties in its family of psilocin analogs Mydecine’s senior director of clinical and regulatory affairs, Jessica Riggleman, noted that psilocybin-assisted therapy has shown meaningful advantages over available medications for tobacco addiction including significant increases in safety and efficacy. “We are looking forward to closely working with the FDA to bring safer and more effective therapy to the millions of people who are trying to quit smoking across the globe,” she said. Mydecine CEO Josh Bartch added that the FDA provided helpful feedback on the study design that the company will implement.  “We are now working rapidly in preparing our IND submission for the 2B portion of the study which we believe will be next month,” he told investors. “Once cleared, we will move swiftly into patient recruitment. This is a study we have been diligently working on over the last two years and we’re excited to continue moving it forward.” Contact Ritika at [email protected]