MIRA Pharma: Ketamir-2 Surpasses FDA-Approved Gabapentin and Pregabalin for Neuropathic Pain in Preclinical Study

MIAMI, FL / ACCESSWIRE / October 21, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a company in the pre-clinical stage of pharmaceutical development, has announced that its new oral ketamine analog, Ketamir-2, has exhibited superior pain relief compared to FDA-approved treatments Gabapentin (Neurontin) and Pregabalin (Lyrica). As a non-opioid, Ketamir-2 represents a promising solution for patients looking for effective neuropathic pain relief without the addiction risks or severe side effects associated with current medications.

In a recent preclinical study using a nerve ligation-induced neuropathy model in female rats, low doses of oral Ketamir-2 resulted in significant pain relief by the 15th day. By the 22nd day, Ketamir-2's pain relief efficacy was up to 112% more effective than Pregabalin and 70% more effective than Gabapentin at higher doses. These results corroborate previous studies in male rats, where Ketamir-2 completely reversed neuropathic pain, while oral ketamine had no effect. This consistency in efficacy across different models underscores Ketamir-2’s potential for providing superior relief through oral administration, positioning it as a promising alternative to existing treatments.

Neuropathic pain is an increasing global health issue, with rising prevalence linked to conditions such as diabetes, chemotherapy-induced nerve damage, and post-herpetic neuralgia. The large and growing market for treatments like Gabapentin and Pregabalin reflects the demand for effective pain management. Gabapentin sales are expected to reach $4.95 billion by 2033, growing at a 6.12% compound annual growth rate. Similarly, the Pregabalin market is projected to grow to $2.2 billion by 2032.

Despite their widespread use, these drugs have significant side effects that limit their long-term effectiveness. Gabapentin’s long-term use can lead to drowsiness, dizziness, cognitive impairment, and weight gain, along with the potential for misuse and withdrawal symptoms. Pregabalin, being a controlled substance, carries a risk of dependence. Patients frequently report weight gain, edema, cognitive issues, and withdrawal symptoms when discontinuing the drug.

Ketamir-2 offers several advantages over current treatments. It is non-habit forming, unlike Pregabalin, making it safer for long-term use. The preclinical data demonstrates that Ketamir-2 provides superior pain relief compared to Pregabalin and Gabapentin. Additionally, Ketamir-2 has the potential to avoid sedation and cognitive impairment, offering an improved quality of life compared to existing treatments.

MIRA Pharmaceuticals is preparing to launch preclinical trials for post-traumatic stress disorder (PTSD), recognizing the urgent need for non-addictive treatments for PTSD. The growing mental health crisis underscores the necessity for effective alternatives to current PTSD medications, and Ketamir-2 has the potential to fill that need. The company is also actively seeking government grants for PTSD and other indications, leveraging increased public focus and funding initiatives aimed at mental health treatment. These grants could expedite the development and delivery of Ketamir-2 to patients suffering from PTSD, depression, and other neuropsychiatric conditions.

MIRA is on schedule to submit an Investigational New Drug (IND) application for Ketamir-2 by the end of the year and is preparing for Phase 1 clinical trials set to begin in the first quarter of 2025. The company aims to commence Phase 2 trials in the last quarter of 2025, potentially showing the first signs of human efficacy by the end of that year. As part of these preparations, MIRA is pursuing scientific publications to share progress and insights with the broader medical community. Ongoing preclinical studies are evaluating Ketamir-2’s impact on chemotherapy-induced neuropathy, a condition that, if proven effective, could qualify the drug for FDA breakthrough designation, potentially shortening the regulatory timeline. The company is also conducting further studies for diabetic neuropathy, expanding the therapeutic potential of Ketamir-2.

Erez Aminov, Chairman and CEO of MIRA Pharmaceuticals, expressed commitment to bringing this breakthrough drug to patients swiftly while supporting every step with strong science. Ketamir-2 has the potential to address not only neuropathic pain but also PTSD and depression. Dr. Angel, Chief Scientific Advisor at MIRA Pharmaceuticals, highlighted the remarkable preclinical results and the strong promise of Ketamir-2 as the company advances it through development.

MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) specializes in developing treatments for neurologic and neuropsychiatric disorders. It holds the exclusive rights for Ketamir-2 in the U.S., Canada, and Mexico. Additionally, MIRA's oral pharmaceutical marijuana analog, MIRA-55, is under investigation for treating anxiety and cognitive decline, often associated with early-stage dementia. If approved, MIRA-55 could significantly advance treatment for various neuropsychiatric, inflammatory, and neurologic diseases and disorders. The U.S. Drug Enforcement Administration has concluded that neither Ketamir-2 nor MIRA-55 would be considered controlled substances or listed chemicals under the Controlled Substances Act.