MIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA

MIAMI, FL – On December 19, 2024, MIRA Pharmaceuticals, Inc. revealed that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Ketamir-2. This novel oral ketamine analog is developed for the treatment of neuropathic pain. MIRA Pharmaceuticals, a company in its preclinical stage, is advancing therapies for neurological and neuropsychiatric disorders. The IND submission signifies a crucial step forward for MIRA's leading drug candidate and showcases its dedication to achieving its milestones.

Erez Aminov, the Chairman and CEO of MIRA, emphasized the significance of this submission. He noted that Ketamir-2 has shown exceptional potential in treating neuropathic pain and has broader possibilities for other major neuropsychiatric conditions. Aminov expressed anticipation for the upcoming Phase I trials, highlighting the company's mission to address unmet medical needs.

The IND application includes extensive data on Ketamir-2’s pharmacology, pharmacokinetics, and toxicology, supported by both in vitro and in vivo studies. These studies encompass validated models of neuropathic pain. Concurrently, the company is preparing to conduct a neurotoxicity study, which aligns with the FDA's feedback to the pre-IND documentation.

According to a report by Fortune Business Insights, the neuropathic pain market in North America is valued at $3.1 billion, with an expected growth rate of 6-7% annually, projected to reach $4.5 billion by 2030. Despite this growth, current treatment options remain insufficient. Commonly prescribed medications like gabapentin and pregabalin have limited effectiveness and are associated with side effects such as sedation and dizziness. Opioids are frequently used but pose risks of dependency and addiction, while intravenous ketamine, though effective for some, requires invasive administration and can induce psychotropic effects like hallucinations.

Ketamir-2 is designed to overcome the limitations associated with existing treatments by selectively targeting the NMDA receptor. Its specific binding results in a reduced risk of the psychotropic effects often linked to traditional ketamine use. Additionally, Ketamir-2 is not a substrate for P-glycoprotein (P-gp), enhancing its oral absorption and penetration of the blood-brain barrier. Unlike traditional forms of ketamine, Ketamir-2 does not induce sedation or hyperactivity, which are common side effects associated with certain psychiatric conditions. As a non-opioid therapy, it aims to eliminate the risks of dependency and addiction. Furthermore, the Drug Enforcement Administration (DEA) has ruled that Ketamir-2 is not a controlled substance, simplifying its accessibility and reducing regulatory challenges.

Preclinical studies have shown Ketamir-2's efficacy in achieving full pain reversal, normalizing pain thresholds in validated neuropathic pain models. It has also demonstrated a strong safety profile across various assessments, including cardiovascular, central nervous system, and respiratory evaluations.

Dr. Itzchak Angel, MIRA’s Chief Scientific Advisor, highlighted the drug's selective action, its solid safety profile, and its effectiveness in pain reversal, pointing to its potential as a transformative treatment. With the IND now submitted, MIRA plans to initiate Phase I Clinical Trials in the first quarter of 2025 to assess the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers. Phase IIa trials are anticipated later in 2025 to evaluate its efficacy in patients with neuropathic pain. Beyond this, MIRA is investigating other potential uses for Ketamir-2, including in treatment-resistant depression and post-traumatic stress disorder.

MIRA Pharmaceuticals, Inc. is a pre-clinical-stage pharmaceutical company with two neuroscience programs targeting a variety of neurologic and neuropsychiatric disorders. MIRA holds exclusive rights for Ketamir-2 in the U.S., Canada, and Mexico. The company is also developing MIRA-55, an oral pharmaceutical marijuana analog aimed at treating anxiety and cognitive decline, often seen in early-stage dementia. If approved by the FDA, MIRA-55 could significantly advance the treatment of various neuropsychiatric and neurologic conditions.