Mira Pharmaceuticals reports Ketamir-2 data in PTSD

MIRA Pharmaceuticals (MIRA) announced results demonstrating that its oral drug candidate Ketamir-2 restored normalized behavior in stressed animals within a validated model of post-traumatic stress disorder. Ketamir-2 is currently being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, where it has shown a favorable safety profile to date. This proof-of-concept validation study was conducted in a small group of rats using the Single Prolonged Stress model, a widely accepted paradigm for inducing inescapable stress that mimics PTSD symptoms in animals. Animals were exposed twice to a predator stressor, which is known to induce “depression-like” symptoms and changes in active/passive coping. Increased immobility after stress exposure reflects enhanced affective impairment or reduced stress resilience. Following the development of these symptoms, animals were dosed orally with Ketamir-2 once daily for five consecutive days. Behavioral assessments included anxiety- and coping/resilience-related behavior in the forced swim test, which measures immobility versus active coping strategies. Outcome: stressed animals displayed hallmark PTSD-like behaviors, including increased despair, immobility, and avoidance of coping. Treatment with Ketamir-2 reversed these types of behaviors, restoring them toward the level observed in non-stressed animals. This initial validation supports the study design, and a larger follow-on PTSD study is ongoing.