Mydecine Innovations Group Inc (OTC:MYCOF, NEO:MYCO). said it has received conditional approval from the Institutional Review Board (IRB) for its multi-site Phase 2b smoking cessation trial, pending US Food and Drug Administration (FDA) approval of its Investigational New Drug (IND) application.
The Denver-based biotech company previously announced that it held a positive 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.
The company plans to submit the IND application in the second quarter of 2022 and is hopeful it will go into effect 30 days after submission.
READ: Mydecine Innovation Group reports positive meeting with US FDA for MYCO-001 smoking cessation study
"Upon the near-term clearance of our IND application, which is wholly owned by Mydecine, we will be the first commercial IND approved utilizing psilocybin for the indication of smoking cessation, and one of a small number of organizations with a commercial FDA IND approval, alongside COMPASS Pathways, MindMed and Usona, for a Phase 2 or later stage study assessing a psychedelic compound for any indication,” Mydecine CEO Josh Bartch said in a statement.
“We have a strong patent and regulatory strategy to support this initiative as well as further subsequent approvals.," he added.
The company said it will move rapidly into the patient recruitment phase upon FDA clearance. Mydecine's Phase 2b study is investigating a primary endpoint of six months, indicating it could publish data as early as the fourth quarter of 2023.
Johns Hopkins University will serve as the lead investigational site, it noted.
Mydecine's chief medical officer Dr Rakesh Jetly pointed out that the total economic cost of smoking has been estimated to be more than US$300 billion per year in the US alone.
“Our mission is to bring safer, more effective solutions to address nicotine dependence and other harmful addictions. This conditional approval brings us one step closer to potentially having a positive effect on millions of lives utilizing this innovative treatment program," Jetly said.
Contact the author at jon.hopkins@proactiveinvestors.com