MIRA Pharmaceuticals' Ketamir-2, a novel oral ketamine analog, has demonstrated 60% greater efficacy than gabapentin, an FDA-approved treatment, in reversing chemotherapy-induced neuropathic pain in preclinical studies. The findings, which position Ketamir-2 as a potential breakthrough therapy, were presented at the Pain Therapeutics Summit in Boston on October 28-29, 2024.
Preclinical Study Details
The study utilized a paclitaxel (PTX) model, a common chemotherapy drug known to induce neuropathic pain in mice. Mice were administered PTX every other day for four doses to induce neuropathic pain. Pain sensitivity was then measured using the Von Frey filament (VFF) test. Results showed that Ketamir-2, at an optimal dose of 300 mg/kg on Day 9, led to near-complete normalization of pain sensitivity, surpassing the effects of gabapentin, which only provided moderate relief.
Potential for Accelerated FDA Approval
The promising preclinical data may allow Ketamir-2 to qualify for 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 designation could expedite the drug's path to market, offering a new treatment option for patients with limited alternatives.
Development Plans and Further Research
MIRA Pharmaceuticals is expanding its research to assess 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 Phase I clinical trials expected to begin in the first quarter of 2025. MIRA is also considering parallel Phase II trials targeting neuropathic pain across different patient populations to accelerate the drug's development.
Addressing Unmet Needs in Pain Management
Existing treatments like gabapentin and pregabalin are often associated with side effects such as cognitive impairment, weight gain, and dependency risks. Ketamir-2, as a non-opioid, offers a potentially safer and more effective approach to pain relief without these drawbacks, making it a promising option for long-term management of neuropathic pain.
Erez Aminov, Chairman and CEO of MIRA, stated, "Ketamir-2 has demonstrated exceptional efficacy across multiple models, achieving complete pain normalization where other treatments fall short. The potential for breakthrough therapy designation further highlights its promise to transform neuropathic pain management and accelerate access for patients in need."
