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MIRA Pharmaceuticals' Formulated Shows Greater Efficacy Than FDA-Approved Drug For Chemo-Induced Neuropathic Pain

Benzinga ·  Oct 29 01:41

MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) stock is trading higher on Monday after the company released new preclinical findings from Ketamir-2, a novel oral ketamine analog.

The new preclinical data show that Ketamir-2 is 60% more effective than the FDA-approved neuropathic pain treatment gabapentin in reducing chemotherapy-induced pain.

The study used the paclitaxel (PTX) model, in which a common chemotherapy drug, PTX, was administered to mice to induce neuropathic pain.

Also Read: MIRA Pharmaceuticals' Oral Ketamine Analog Achieves Complete Normalization Of Neuropathic Pain In Animal Studies

While effective in treating cancer, PTX often causes nerve damage, leading to chemotherapy-induced neuropathy characterized by pain, numbness, and tingling.

To assess Ketamir-2's efficacy, mice received PTX every other day for four doses, and pain sensitivity was measured using the Von Frey filament (VFF) test.

On Day 9, at the optimal dose of 300 mg/kg, Ketamir-2 led to near-complete normalization of pain sensitivity, outperforming FDA-approved gabapentin by 60%, which provided only moderate relief.

The company will present these findings and data from previous studies at the upcoming Pain Therapeutics Summit.

The company is preparing to submit an Investigational New Drug (IND) application by the end of 2024, with plans to begin Phase I clinical trials in the first quarter of 2025.

To maximize the development timeline, MIRA is considering conducting multiple Phase 2 trials in parallel, specifically targeting neuropathic pain across different patient populations, which could further accelerate Ketamir-2's path to market.

In addition to the ongoing studies, MIRA is in the process of submitting several scientific journal publications that detail 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.

Price Action: MIRA stock is up 40.30% at $1.81 at the last check on Monday.

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