Mira Pharmaceuticals Progresses Preclinical Trials for Ketamir-2 IND Submission This Year

MIRA Pharmaceuticals, Inc., a pre-clinical-stage pharmaceutical enterprise concentrating on neurological and neuropsychiatric disorders, has announced significant progress in its development endeavors related to Ketamir-2. This innovative oral ketamine analog is being examined for treating severe PTSD, depression, and various forms of neuropathic pain, including cancer-related pain.

Currently, MIRA is conducting preclinical studies utilizing Ketamir-2, an oral form of ketamine distinct from the traditional intravenous or intranasal forms. These studies are pivotal in moving towards clinical trials set for 2025. The company plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) by year’s end, which, if approved, would allow for human clinical trials.

MIRA has initiated a collaborative preclinical trial with Pharmaseed Ltd. to compare Ketamir-2 with traditional ketamine in treating severe PTSD in rats. The trial aims to measure how effective Ketamir-2 is in alleviating symptoms of chronic stress and dysfunctional fear memory processing. This study will not only look at behavioral outcomes but will also delve into biomarker analysis and immunohistochemistry to understand the biological underpinnings of Ketamir-2’s potential benefits.

In addition to PTSD studies, MIRA is conducting preclinical trials with Biotrial, Inc. to evaluate Ketamir-2's impact on spontaneous locomotor activity in mice. This research aims to decipher the drug's effects on movement and coordination compared to ketamine. Ketamine is known for its biphasic effect on locomotion, where different doses have varying impacts. These head-to-head studies will provide crucial data on Ketamir-2’s pharmacodynamic properties and potential side effects.

Furthermore, MIRA has begun 7-day toxicology studies in rats and dogs with Frontage Laboratories, an essential step toward ensuring Ketamir-2’s safety and efficacy before human trials. These studies are integral to the regulatory process and help pave the way for future clinical applications.

On the manufacturing front, MIRA has made strides in optimizing the production process of Ketamir-2. These advancements have simplified synthesis and reduced production costs, essential for scaling up under Good Manufacturing Practices (GMP). This efficiency is crucial as the company gears up for the required regulatory toxicology studies to support the IND application.

The potential of Ketamir-2 extends beyond PTSD. According to the National Institutes of Health, PTSD affects around 8 million adults in the U.S. annually, with current treatments often falling short. Ketamir-2 offers a promising alternative due to its rapid antidepressant effects and improved safety profile. It targets NMDA receptors in the brain, essential for synaptic plasticity and cognitive function, promising more effective and faster relief from PTSD symptoms than traditional SSRIs and benzodiazepines.

MIRA is also exploring collaborations with various research centers to investigate Ketamir-2’s efficacy in treating cancer pain. These collaborative efforts could accelerate the IND submission process and broaden the therapeutic applications of Ketamir-2.

Erez Aminov, Chairman and CEO of MIRA Pharmaceuticals, highlighted the significance of these developments, emphasizing the urgent need for advanced treatments for mental health disorders and neuropathic pain. He pointed out the substantial financial burden of medication-treated major depressive disorder in the U.S., amounting to $92.7 billion annually. Aminov expressed hope that Ketamir-2 could address these critical public health issues.

Dr. Itzchak Angel, Chief Scientific Advisor of MIRA Pharmaceuticals, added that the data from these studies would be invaluable in demonstrating Ketamir-2’s potential benefits. He noted that Ketamir-2's high oral bioavailability and lack of mu opioid interaction make it a potentially safer and more effective option for home administration, offering rapid relief for depression and other mental health conditions.

MIRA Pharmaceuticals remains committed to advancing its neuroscience programs, aiming to bring innovative solutions to patients with neurologic and neuropsychiatric disorders. The company holds exclusive rights for Ketamir-2 in the U.S., Canada, and Mexico, and is also investigating other novel treatments like MIRA-55 for anxiety and cognitive decline.