MIRA Pharmaceuticals Reveals Preclinical Success: Ketamir-2 Optimized for Brain Delivery, Avoiding Ketamine's Drug Resistance
New findings highlight potential advantages of MIRA's novel oral ketamine analog for treating neurological and neuropsychiatricdisorders
MIRA Pharmaceuticals, Inc. , a leading pre-clinical-stage pharmaceutical company, today announced new preclinical study results for its novel oral ketamine analog, Ketamir-2.
The additional data announced today continues a string of promising preclinical results announced by MIRA in recent months for Ketamir-2 as MIRA works towards its goal of submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) by the end of this year which, if granted, would allow for human testing of Ketamir-2.
Ketamir-2 is under investigation for its potential in treating neurological and neuropsychiatric disorders, including depression, treatment-resistant depression (TRD), and post-traumatic stress disorder (PTSD).
Ketamir-2 has demonstrated in in vitro studies that it is not a substrate for interaction with P-glycoprotein (P-gp), a membrane protein that typically pumps many drugs out of cells, including cells located in the brain. This characteristic might allow Ketamir-2 to have a better oral absorption and to penetrate the blood-brain barrier more effectively than traditional ketamine, which is a substrate of P-gp.
Traditional ketamine requires intravenous (IV) administration, necessitating hospital visits and medical supervision. As an oral formulation, Ketamir-2 could potentially offer greater convenience and improved patient compliance if further studies confirm these benefits.
MIRA's preclinical also suggest that improved penetration into target tissues would allow for lower doses of Ketamir-2 to achieve therapeutic effects.
MIRA previously announced that Ketamir-2's oral bioavailability is predicted to be around 80%, significantly higher than traditional ketamine's less than 30%. Recent studies further highlight Ketamir-2's anti-depressive and anxiolytic effects in a mouse model, with significant improvements in behavioral tests compared to traditional ketamine.
Building on these promising preclinical results, MIRA has additional ongoing preclinical studies to demonstrate Ketamir-2's potential efficacy in treating chemotherapy-induced depression and cancer-related neuropathic pain. Due to its novel chemical profile, MIRA is exploring options for orphan drug indications such as multiple sclerosis-induced depression and Huntington's disease-induced depression. Models are being developed to validate these designations and ongoing studies have been designed to help support these efforts.
July 24, 2024
