MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) has unveiled a strategic collaboration with MIRALOGX, LLC, an intellectual property holding company established by MIRA's founder. This partnership grants MIRA exclusive development and commercialization rights for Ketamir-2 in the U.S., Canada, and Mexico, marking a significant advancement in the landscape of treatments for depressive disorders. MIRA is set to receive a $3 million line of credit from MIRALOGX, dedicated to funding the initial stages of Ketamir-2 development.

Ketamir-2, a proprietary compound currently under investigation, shows promise in delivering ultra-rapid antidepressant effects within four hours of dosing. This development is particularly encouraging for individuals facing treatment-resistant depression (TRD) and major depressive disorder with suicidal ideation (MDSI). Notably, while Ketamine is categorized as a Schedule III controlled substance by the U.S. Drug Enforcement Administration (DEA), Ketamir-2 has been determined by the DEA to be outside the purview of controlled substances under the Controlled Substances Act.

Dr. Adam Kaplin, MD, PhD, MIRA's President and Chief Scientific Officer, and an esteemed figure in ketamine research, will spearhead the development of Ketamir-2. Dr. Kaplin, with a background as the Johns Hopkins site Principal Investigator for clinical trials leading to esketamine's approval, brings significant expertise to the project.

A distinctive aspect of Ketamir-2 is its potential for superior bioavailability, as suggested by recent pre-clinical studies. Unlike Ketamine, which typically requires non-oral administration, Ketamir-2 exhibits a more favorable gastrointestinal absorption profile in preliminary studies. Moreover, Ketamir-2 is designed to target specific receptors, potentially reducing side effects associated with ketamine, such as sedation, addiction, dissociative symptoms, and cardiovascular concerns.

Dr. Kaplin expressed optimism about Ketamir-2's development, emphasizing its potential to transform the lives of those suffering from TRD and suicidal depression. Notably, the oral availability and predicted favorable side effect profile may pave the way for FDA approval for convenient home self-administration, distinguishing it from existing treatments like Spravato.

MIRA, underscored the shared vision between MIRA and MIRALOGX in advancing mental health research. The partnership aims to address mental health challenges with transformative solutions, positioning both MIRA1a and Ketamir-2 to maximize their impact on advancing mental illness treatment. The exclusive licensing agreement and the initial funding from MIRALOGX's line of credit mark an exciting phase of innovation and development for MIRA.

 

Source: prnewswire.com

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