MIRA Pharmaceuticals, Inc. announced new compelling preclinical results for its investigational compound, Ketamir-2, a novel oral ketamine analog. The new data highlights Ketamir's potential to provide therapeutic benefits without inducing schizophrenia-like behavior or hyper-locomotor activity. These results follow the release of positive preclinical efficacy data for Ketamir-2 earlier in June, which collectively are forming the basis of an Investigational New Drug Application (IND) that MIRA plans to submit to the U.S. Food and Drug Administration (FDA) for Ketamir-2 by the end of this year.

Background on the Current Preclinical Study: MIRA conducted the latest rigorous preclinical studies in collaboration with Biotrial to evaluate the effects of Ketamir-2 on spontaneous locomotor activity in mice. The studies are particularly significant for the treatment of mental health disorders and pain management, presenting a major advancement in the development of safer and more effective therapeutic options. Ketamine-induced hyperlocomotion is considered a schizophrenia-like effect because it models the hyperactive and psychotic symptoms observed in schizophrenia patients.

The hyperlocomotion induced by traditional ketamine is mediated by increased dopamine release and turnover in the nucleus accumbens, a brain region implicated in the positive symptoms of schizophrenia, such as psychosis. Antipsychotic drugs like haloperidol, which block dopamine receptors, can reduce the effect of ketamine-induced hyperlocomotion, further linking this behavior to the dopaminergic dysregulation hypothesized in schizophrenia. Key Findings from the Study: Reduced Psychotic-like Symptoms: Unlike traditional ketamine, which resulted in marked and significant hyperlocomotion, Ketamir-2 did not produce incidences of inducing hyperlocomotion, schizophrenia-like behaviors in animal models, indicating a potentially safer profile for human patients, especially those with a predisposition to psychotic disorders.

No Hyper-locomotor Activity: The study showed that while traditional ketamine induced hyperlocomotion, Ketamir-2, at same and higher doses compared with traditional ketamine, did not result in the hyper-locomotor activity, reducing the potential for misuse and enhancing patient safety. Implications for Patient Care and Market Potential: Safety and Tolerability: By mitigating adverse effects commonly linked with traditional ketamine, Ketamir-2 potentially represents a significant leap forward in developing effective and patient-friendly treatments for certain mental health disorders and neuropathic pain. This improvement is crucial for long-term patient compliance and overall treatment success.

Broader Therapeutic Applications: Ketamir-2's different profile with enhanced safety features allows for its potential use in a wider range of psychiatric and neurologic conditions, expanding its applicability beyond current ketamine treatments. This potentially positions Ketamir-2 as a versatile option in the pharmaceutical landscape. Economic Impact: With the financial burden of treatment-resistant depression alone accounting for $43.8 billion annually in the U.S., Ketamir-2's development could lead to substantial cost savings in healthcare by providing a more efficient and safer treatment alternative.

MIRA is on track to submit an IND application for Ketamir-2 to the FDA by the end of this year. This submission will mark a significant milestone in advancing Ketamir-2 toward clinical trials and eventually making it available to patients in need. Additionally, MIRA is conducting further safety and efficacy studies on Ketamir-2 to further demonstrate its improved profile compared to traditional ketamine.

MIRA's commitment to advancing research includes further studies on Ketamir-2 for cancer pain and PTSD, aiming to provide effective and safe treatment options for these challenging conditions.