MIRA Pharmaceuticals (NASDAQ:MIRA) Validates Ketamir-2’s Safety Profile with No Adverse Findings, Paving the Way for IND Submission by Year-End

MIRA Pharmaceuticals, Inc. (the “Company”), a preclinical-stage pharmaceutical development company, has successfully completed its current Good Laboratory Practice (GLP) preclinical safety program for Ketamir-2, a novel oral ketamine analog. The results from these studies revealed no adverse findings, marking a significant milestone toward the submission of the Company’s Investigational New Drug (IND) application by the end of 2024.

The preclinical safety program encompassed evaluations across cardiovascular, central nervous system (CNS), and respiratory systems, as well as toxicology studies. Key findings indicated the following:

– Cardiovascular Safety in Dogs: No adverse effects were observed at therapeutic doses.
– CNS Assessment in Rats: No significant changes were noted at therapeutic dose levels; high-dose effects were transient and non-disruptive.
– Respiratory Safety in Rats: No effects were detected across all tested doses.
– 14-Day Toxicology in Dogs: Ketamir-2 was well-tolerated at daily doses up to 200 mg/kg, with no observed adverse effects.
– Ames Test: Ketamir-2 was confirmed to be non-mutagenic.

The Company intends to kick off Phase I clinical trials for Ketamir-2 in the first quarter of 2025, focusing on its safety, tolerability, pharmacokinetics, and pharmacodynamics. This trial will incorporate pain evaluation metrics to assess Ketamir-2’s potential in treating neuropathic pain and psychosis, with preliminary data anticipated by the second quarter of 2025.

A cautionary note regarding forward-looking statements was included in the press release, highlighting that the statements made by MIRA Pharmaceuticals are forward-looking and subject to risks and uncertainties that could differ materially from the anticipated results. The Company emphasized its disclaimer regarding the obligation to update any forward-looking statements except where required by law.

Pursuant to the requirements of the Securities Exchange Act of 1934, the report was signed by the Chief Executive Officer, Erez Aminov, on behalf of MIRA Pharmaceuticals, Inc. on December 10, 2024.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read MIRA Pharmaceuticals’s 8K filing here.

About MIRA Pharmaceuticals

MIRA Pharmaceuticals, Inc operates as a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a range of neurologic and neuropsychiatric disorders. The company holds exclusive U.S., Canadian, and Mexican rights for Ketamir-2, a patent pending oral ketamine analog under investigation to deliver ultra-rapid antidepressant effects for individuals battling treatment-resistant depression, major depressive disorder with suicidal ideation, and post-traumatic stress disorder.