Mydecine Innovations Group Inc. announced it has received conditional approval from the Institutional Review Board (IRB) for its multi-site Phase 2b smoking cessation trial. Johns Hopkins University will serve as the lead investigational site. The Company reported the IRB has approved its Phase 2b smoking cessation study pending FDA approval of its Investigational New Drug (IND) application.

Mydecine plans to submit the IND application in Second Quarter 2022 and is hopeful it will go into effect 30 days after submission. The Company 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 Fourth Quarter 2023.