MIRA Pharmaceuticals' novel oral ketamine analog, Ketamir-2, has demonstrated significantly greater efficacy than gabapentin, an FDA-approved treatment, in reducing chemotherapy-induced neuropathic pain in preclinical studies. The findings highlight a potential advancement in managing a debilitating side effect of chemotherapy, offering hope for improved patient outcomes.
The preclinical data revealed that Ketamir-2 is 60% more effective than gabapentin in alleviating neuropathic pain induced by chemotherapy. The study employed the paclitaxel (PTX) model, where mice were administered PTX, a common chemotherapy drug known to cause nerve damage and subsequent neuropathic pain characterized by pain, numbness, and tingling.
To evaluate Ketamir-2's effectiveness, mice received PTX every other day for a total of four doses. Pain sensitivity was then measured using the Von Frey filament (VFF) test. On Day 9, at the optimal dose of 300 mg/kg, Ketamir-2 resulted in near-complete normalization of pain sensitivity, surpassing the performance of gabapentin, which only provided moderate relief.
MIRA Pharmaceuticals is preparing to submit an Investigational New Drug (IND) application by the end of 2024, with plans to commence Phase I clinical trials in the first quarter of 2025. To expedite the development timeline, the company is considering conducting multiple Phase 2 trials in parallel, specifically targeting neuropathic pain across different patient populations. This approach could potentially accelerate Ketamir-2's path to market.
Further Research and Development
In addition to the ongoing studies, MIRA is in the process of submitting several scientific journal publications detailing Ketamir-2's mechanism of action, as well as the results from its pain and depression studies. Furthermore, Ketamir-2 is under evaluation for post-traumatic stress disorder (PTSD), with preclinical studies currently underway. MIRA is actively seeking government grants to support research on PTSD and other indications.
Implications for Neuropathic Pain Treatment
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and often dose-limiting side effect of many chemotherapeutic agents, affecting a significant proportion of cancer patients. Current treatments, including gabapentin and other analgesics, often provide inadequate relief, leaving a substantial unmet medical need. The superior efficacy demonstrated by Ketamir-2 in preclinical models suggests a potential for improved pain management and quality of life for patients undergoing chemotherapy.
