MIRA Pharmaceuticals' Ketamir-2, a novel oral ketamine analog, has demonstrated 60% greater efficacy than gabapentin, an FDA-approved treatment, in reducing chemotherapy-induced neuropathic pain in preclinical studies. The findings highlight Ketamir-2's potential as a breakthrough therapy in pain management, particularly for cancer-related neuropathic pain.
Preclinical Study Details
The study utilized the paclitaxel (PTX) model, a well-established method for inducing neuropathic pain in mice. Mice were administered PTX, a common chemotherapy drug known to cause nerve damage and subsequent neuropathic pain. Ketamir-2 was administered at an optimal dose of 300 mg/kg on Day 9, resulting in near-complete normalization of pain sensitivity. This significantly outperformed gabapentin, which only provided moderate relief.
Implications for Breakthrough Therapy Designation
The promising results could pave the way for Ketamir-2 to receive FDA breakthrough therapy designation, fast track, and/or priority review, especially for rare forms of cancer-related neuropathic pain, such as that associated with Multiple Myeloma. Managing neuropathic pain in these patients is challenging due to limited effective treatments. By targeting this specific patient population, Ketamir-2 could potentially qualify for accelerated FDA commercialization pathways.
Development Plans and Future Studies
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 Phase I clinical trials expected to begin in the first quarter of 2025. MIRA is also considering conducting multiple Phase II trials in parallel, targeting neuropathic pain across different patient populations to expedite the drug's path to market.
Addressing Unmet Needs in Pain Management
Ketamir-2, as a non-opioid, aims to address the limitations of existing treatments like gabapentin and pregabalin, which 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 a potentially superior option for long-term management.
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."
