MIRA Pharmaceuticals Announces Absence of Neurotoxicity in Ketamir-2 Study

MIRA Pharmaceuticals reported promising preclinical results for its drug candidate, Ketamir-2. The study, mandated by the FDA before human trials, showed no brain toxicity in animal models. These findings bolster Ketamir-2's safety profile, essential for its role as a potential alternative to ketamine in treating neurological disorders.

The absence of Olney lesions and other neurotoxic signs in rats strengthens Ketamir-2's position. Its reduced affinity for the PCP binding site differentiates it from traditional NMDA receptor antagonists, minimizing typical neurotoxic effects.

As MIRA advances its Phase I clinical trial, the results of this study support ongoing development and regulatory submissions. The company is gearing up for a Phase IIa trial aimed at evaluating its efficacy in diabetic neuropathic pain patients, with ambitions for smoother regulatory paths due to Ketamir-2's non-controlled substance classification.