Mydecine Innovations has reported a positive pre-investigational new drug (IND) meeting with America’s Food and Drug Administration (FDA) regarding its psychedelic compound for smoking cessation.
Previous research has shown psychedelic compounds could be helpful for smoking cessation – in particular, psilocybin-assisted psychotherapy.
In 2021, to explore this further, the National Institutes of Health’s National Institute on Drug Abuse awarded a $4m grant for the first time in 50 years to research the impact of psilocybin on tobacco addiction.
The grant was awarded to Johns Hopkins University, where principal investigator Dr Matthew Johnson is carrying out a three-year, multisite study in collaboration with the University of Alabama, Birmingham and New York University.
For the study, Mydecine Innovations Group, which has a five-year research agreement with Johns Hopkins University to study the impact of psychedelics on smoking cessation as well as other initiatives, is supplying its lead drug candidate, MYCO-001. The compound is 99 per cent pure psilocybin.
Mydecine’s chief medical officer, Dr Rakesh Jetly, commented: “The data from John Hopkins University’s ongoing studies assessing psychedelic-assisted therapy to treat nicotine addiction is showing efficacy rates two to three times higher than the current gold standard of treatment.
“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.”
In 2021 the company partnered with Johnson to carry out a Phase II and III smoking cessation clinical trial for the compound, which will run concurrently with the Johns Hopkins University study.
Mydecine, which is based in Denver, Colorado, USA, with international offices in the Netherlands, has now announced a positive meeting with the FDA regarding the compound and breakthrough therapy status applications.
“Mydecine plans to submit a request for Breakthrough Therapy designation with our IND submission,” added senior director of clinical and regulatory affairs, Jessica Riggleman.
“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.”
CEO Josh Bartch added: “We had an extremely positive meeting with the FDA in regards to our proposed smoking cessation study. The FDA provided helpful feedback on our study design that we 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. 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.”
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