MIRA Pharmaceuticals has announced preclinical results for Ketamir-2, a novel oral ketamine analog, demonstrating 60% greater efficacy than gabapentin in reducing chemotherapy-induced neuropathic pain. The findings, which will be presented at the Pain Therapeutics Summit in Boston, highlight Ketamir-2's potential as a breakthrough therapy in pain management.
Preclinical Study Details
The study utilized a paclitaxel (PTX) model, where mice were administered PTX to induce neuropathic pain, a common side effect of chemotherapy. Ketamir-2, at a dose of 300 mg/kg, led to near-complete normalization of pain sensitivity, significantly outperforming gabapentin, an FDA-approved treatment, which only provided moderate relief. Pain sensitivity was measured using the Von Frey filament (VFF) test.
Potential Regulatory Pathways
The promising results could pave the way for Ketamir-2 to receive FDA breakthrough therapy designation, fast track, and/or priority review, particularly for rare forms of cancer-related neuropathic pain, such as that associated with Multiple Myeloma. This could significantly reduce the time to market and accelerate patient access to the drug.
Clinical Development Plans
MIRA is advancing its pipeline with studies assessing Ketamir-2 for diabetic neuropathy and other conditions. The company plans to submit an Investigational New Drug (IND) application by the end of 2024, with plans to begin Phase I clinical trials in the first quarter of 2025. Multiple Phase II trials may be conducted in parallel to expedite Ketamir-2's path to market.
Addressing Unmet Needs in Pain Management
Existing treatments like gabapentin and pregabalin often come with side effects such as cognitive impairment, weight gain, and dependency risks. Ketamir-2 offers consistent and safer pain relief without these drawbacks, making it an ideal option for long-term management.
"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."
