MIRA Pharmaceuticals shares updates on the ongoing pre-clinical studies of its investigational compound, Ketamir-2, a novel oral ketamine analog which could potentially deliver ultra-rapid antidepressant effects. MIRA is conducting pre-clinical studies of Ketamir-2 in collaboration with Frontage Laboratories as a potential treatment for individuals battling treatment-resistant depression, or TRD, major depressive disorder with suicidal ideation, or MDSI, and post-traumatic stress disorder, or PTSD. MIRA is hopeful that the encouraging results of these most recent studies will enable MIRA to file an Investigational New Drug Application, or IND, with the FDA by the end of this year which, if accepted, would allow for human testing of Ketamir-2. The latest in vitro research focused on Ketamir-2’s stability in the bloodstream, its metabolism, and how it binds to proteins in the blood. These factors play a crucial role in determining a drug’s adequacy and likelihood for acceptable safety, its pharmacological profile and potential modes of administration to patients. Ketamir-2 demonstrated excellent stability in blood from various species, including humans. The studies indicate the potential for Ketamir-2 to be metabolized effectively and safely. Ketamir-2 appears to bind optimally to blood proteins, which suggests the potential for effective delivery throughout the body. Initial toxicology assessments provide a favorable safety profile crucial for advancement through regulatory review and clinical trials.
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