MIRA Pharmaceuticals Inc. (NASDAQ: MIRA) has announced that its experimental ketamine-based drug, Ketamir-2, has demonstrated superior pain relief compared to currently available treatments for neuropathic pain in preclinical studies. The findings suggest that Ketamir-2, a non-opioid, could offer a more effective and safer alternative for patients seeking relief from neuropathic pain.
Ketamir-2 Outperforms Existing Treatments
According to the company's press release, Ketamir-2 showed up to 112% more effective results than pregabalin (Lyrica) and 70% greater relief than gabapentin (Neurontin) at higher doses in a nerve ligation-induced neuropathy model using female rats. These results build upon previous studies in male rats, where Ketamir-2 achieved complete reversal of neuropathic pain, while oral ketamine showed no effect. The consistent efficacy across different models highlights Ketamir-2's potential to deliver superior pain relief through oral administration.
Advantages of Ketamir-2
Ketamir-2 offers several potential advantages over existing treatments. Unlike pregabalin, it carries no known risk of dependence and preclinical data suggests better efficacy than both pregabalin and gabapentin. The company also suggests that Ketamir-2 has the potential to avoid sedation and cognitive impairment, offering an improved quality of life compared to currently available treatments.
Addressing Unmet Needs in Neuropathic Pain Management
Neuropathic pain is a significant global health concern, with its prevalence increasing due to conditions such as diabetes and chemotherapy-induced nerve damage. The market for neuropathic pain treatments is substantial, with gabapentin expected to reach $4.95 billion by 2033 and pregabalin projected to reach $2.2 billion by 2032. However, current treatments often come with significant drawbacks. Gabapentin can cause drowsiness and cognitive impairment, while pregabalin carries risks of dependence and withdrawal symptoms.
Development Plans and Future Indications
MIRA Pharmaceuticals is planning to submit an Investigational New Drug (IND) application to the FDA by the end of 2024, with Phase 1 clinical trials expected to begin in early 2025. The company is also exploring Ketamir-2's potential in treating post-traumatic stress disorder (PTSD) and is pursuing government grants to accelerate development for additional neuropsychiatric conditions. Furthermore, ongoing preclinical studies are evaluating Ketamir-2's impact on chemotherapy and diabetic-induced neuropathy, a condition that, if proven effective, could qualify the drug for FDA breakthrough designation, potentially shortening the regulatory timeline.
Financial Considerations
MIRA Pharmaceuticals reported using approximately $1.9 million in operating activities during the first half of 2024, leaving it with $2.8 million in cash as of June 30. In August, MIRA entered into an At The Market offering agreement to sell up to $19.3 million in common stock.
