MIRA Pharmaceuticals’s stock experienced significant price and volume increases following the company’s announcement that its Ketamir-2 product candidate induced near-complete normalization of pain sensitivity in a mouse model of chemotherapy-induced neuropathy, under experimental conditions where gabapentin provided only moderate relief. Neuropathic pain was induced in mice through administration of four doses of paclitaxel, a common chemotherapy drug. Pain sensitivity was measured using the Von Frey filament test, a mechanical sensitivity test that measures an animal's experience of pain in response to stimuli. To perform the test, animals are placed on a wire mesh surface and calibrated filaments of varying stiffness are applied through the underside of the mesh to the animal’s hind paw, to determine the minimum amount of force required to make the animal withdraw its paw. The force exerted by the filament is inversely proportional to its length and directly proportional to its width. MIRA’s results build on earlier successes across various pain models, further validating Ketamir-2's potential as an effective pain management drug with fewer side effects than gabapentin and pregabalin. Besides chemotherapy-induced pain, MIRA is planning to advance Ketamir-2 for the treatment of diabetic neuropathy.
Neuropathic pain is a expanding health indication, with increasing prevalence linked to conditions like diabetes, chemotherapy-induced nerve damage, and post-herpetic neuralgia. Chronic pain markets are large and growing, with gabapentin (Neurontin) expected to reach $4.95 billion in sales by 2033 and pregabalin (Lyrica) expected to reach $2.20 billion in sales by 2032.
MIRA is on track to submit an Investigational New Drug application for neuropathic pain indications in December 2024 and begin Phase I clinical trials in humans during the first quarter of 2025. MIRA has completed the design of its Phase I clinical trial, which will assess safety, tolerability, and pharmacokinetics in humans. The company’s primary goal is to demonstrate efficacy in humans as early as possible in subsequent Phase II studies.
Looking ahead, MIRA aims to broaden Ketamir-2’s therapeutic applications to include major depressive disorder with suicidal ideation, treatment-resistant depression, and post-traumatic stress disorder, potentially leading to additional IND filings in 2025.
We reiterate our BUY rating and 14-month price target of $7.50.