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MIRA Pharmaceuticals Validates Ketamir-2's Safety Profile With No Adverse Findings, Paving the Way for IND Submission by Year-End
Strong Safety Profile Validated Across Studies, Setting the Stage for Clinical Trials in Neuropathic Pain MIAMI, FL / ACCESSWIRE / December 10, 2024 / MIRA
About this update from Mira Pharmaceuticals, Inc.
[{"type":"text","content":"Strong Safety Profile Validated Across Studies, Setting the Stage for Clinical Trials in Neuropathic Pain MIAMI, FL / ACCESSWIRE / December 10, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company, proudly announces the successful completion of its current Good Laboratory Practice (GLP) preclinical safety program for Ketamir-2, a novel oral ketamine analog. The results confirm no adverse findings, clearing a critical milestone as the Company progresses toward submitting its Investigational New Drug (IND) application by year-end 2024.\"Our commitment to advancing Ketamir-2 into clinical trials as quickly as possible reflects our strategic focus on generating proof-of-concept data that positions MIRA for a potential M&A transaction or strategic partnership,\" said Erez Aminov, CEO and Chairman of MIRA. \"This milestone demonstrates our ability to execute efficiently and reinforces our dedication to delivering innovative, safe, and effective treatments for patients suffering from neuropathic pain.\"The Significance of Safety in Drug DevelopmentSafety is one of the most significant factors influencing the success of drug development and regulatory approval. Industry data shows that nearly 40% of drug failures during clinical development are attributed to safety concerns, making it a primary reason for termination at all stages of research. Additionally, drugs with unresolved safety questions often face post-market challenges, with 30% of FDA-approved drugs receiving post-market safety warnings or label changes.By demonstrating Ketamir-2's robust safety profile in comprehensive preclinical studies, MIRA has significantly de-risked this critical aspect of drug development. This milestone positions the company for a smoother regulatory pathway and potentially increases the likelihood of successful clinical outcomes.Highlights of Preclinical Findings:Cardiovascular Safety in Dogs: No adverse effects were noted at therapeutic doses.CNS Assessment in Rats: No significant CNS changes were observed at therapeutic dose levels, confirming a favorable safety profile. Effects in high-dose groups were limited, transient, and non-disruptive.Respiratory Safety in Rats: No respiratory-related effects were noted across all tested doses.14-Day Toxicology in Dogs: Ketamir-2 was well-tolerated at daily doses up to...