MIRA Pharmaceuticals, a pre-clinical-stage pharmaceutical company, has revealed new preclinical study insights for its novel oral ketamine analog, Ketamir-2. This drug candidate is being investigated as a potential treatment for neurological and neuropsychiatric disorders. The latest results advance MIRA’s goal of submitting an Investigational New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Ketamir-2 later this year.
The preclinical data highlights Ketamir-2 as a selective inhibitor of the NMDA receptor, a key neurotransmitter in the brain. Unlike traditional ketamine, Ketamir-2 interacts specifically at the PCP-binding site of the NMDA complex with a significantly lower affinity, reducing the risk of neurobehavioral side effects such as dissociation and hallucinations. This selective binding avoids interactions with opioid receptors, dopamine and serotonin transporters, and various acetylcholine receptors, offering a cleaner pharmacological profile.
The potential benefits of Ketamir-2’s selectivity include reduced side effects, improved safety, and enhanced therapeutic effectiveness. The drug has shown no toxicity at high doses in toxicology studies with rats and dogs, reinforcing its excellent safety margin. At lower doses, Ketamir-2 demonstrated significant antidepressant and anxiolytic effects, suggesting a promising therapeutic window for safe and effective use in humans.
Erez Aminov, Chairman and CEO of MIRA Pharmaceuticals, highlighted the significance of these findings, noting that the novel selectivity and robust safety data strengthen confidence in Ketamir-2’s potential as a transformative treatment for disorders like depression, treatment-resistant depression, and post-traumatic stress disorder . Chief Scientific Advisor Dr. Itzchak Angel praised the drug’s ability to selectively inhibit a specific site on the NMDA receptor without affecting other sites, underlining its potential as a groundbreaking treatment for mental health disorders.
MIRA’s research also indicates that Ketamir-2 has superior brain penetration and bioavailability, characteristics that enhance its therapeutic potential by effectively crossing the blood-brain barrier. If granted by the FDA, the IND would allow for human clinical trials, bringing Ketamir-2 closer to becoming a new standard of care for neurological and neuropsychiatric disorders.