MIRA Pharmaceuticals (NASDAQ:MIRA) has announced preclinical findings indicating that Ketamir-2, a novel oral ketamine analog, demonstrates 60% greater efficacy than gabapentin, an FDA-approved treatment, in reversing chemotherapy-induced neuropathic pain. The study, utilizing the paclitaxel model in mice, showed that Ketamir-2 achieved near-complete pain normalization at a 300 mg/kg dose, suggesting a potential breakthrough in pain management for cancer patients.
Preclinical Study Details
The study induced neuropathic pain in mice using paclitaxel (PTX), a chemotherapy drug known to cause nerve damage. Mice received PTX every other day for four doses, and pain sensitivity was measured using the Von Frey filament test. On Day 9, Ketamir-2, administered at 300 mg/kg, resulted in near-complete normalization of pain sensitivity, surpassing the efficacy of gabapentin by 60%. Gabapentin provided only moderate relief in comparison.
Development Plans and Regulatory Pathways
MIRA Pharmaceuticals is preparing to submit an Investigational New Drug (IND) application by the end of 2024, with Phase I clinical trials slated to begin in the first quarter of 2025. The company is also considering conducting multiple Phase II trials in parallel to expedite the drug's path to market. The drug could potentially qualify for FDA breakthrough therapy designation, fast track, and priority review for treating rare cancer-related neuropathic pain, such as that associated with Multiple Myeloma.
Broader Therapeutic Potential
In addition to chemotherapy-induced neuropathic pain, MIRA is evaluating Ketamir-2 for diabetic neuropathy, post-traumatic stress disorder (PTSD), and other conditions. Preclinical studies for PTSD are currently underway, and the company is seeking government grants to support further research in these areas.
Addressing Unmet Needs in Pain Management
Existing treatments for neuropathic pain, such as gabapentin and pregabalin, are often associated with side effects like cognitive impairment, weight gain, and dependency risks. Ketamir-2, as a non-opioid, offers a potentially safer alternative for long-term pain management without these drawbacks.
Expert Commentary
"Ketamir-2 has demonstrated exceptional efficacy across multiple models, achieving complete pain normalization where other treatments fall short," said Erez Aminov, Chairman and CEO of MIRA. "The potential for breakthrough therapy designation further highlights its promise to transform neuropathic pain management and accelerate access for patients in need."
Dr. Itzchak Angel, Chief Scientific Advisor at MIRA, added, "The impressive results achieved to date not only validate our approach but also signal a significant leap forward in pain management. We look forward to presenting these findings and discussing Ketamir-2's potential impact at the upcoming Pain Therapeutics Summit."
About MIRA Pharmaceuticals
MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a pre-clinical-stage pharmaceutical development company focused on neurologic and neuropsychiatric disorders. Their pipeline includes Ketamir-2 and MIRA-55, a novel oral pharmaceutical marijuana analog under investigation for treating anxiety and cognitive decline.
