MIRA Pharmaceuticals Initiates Final Cohort Dosing for Ketamir-2 Clinical Trial
MIRA Pharmaceuticals initiated dosing in the final cohort of its Phase 1 multiple ascending dose clinical trial evaluating Ketamir-2, its lead oral NMDA receptor antagonist. To date, 50 healthy volunteers have already been dosed, while dosing in the final cohort is underway, with 6 last subjects remaining. The Company expects to complete the Phase 1 clinical program by the end of the first quarter of 2026. The ongoing randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple oral doses of Ketamir-2 in healthy volunteers. Data reviewed to date continue to support advancement of the program, with no serious adverse events reported. MIRA is actively finalizing its Phase 2a proof-of-concept study in chemotherapy-induced peripheral neuropathy, including clinical site selection, and plans to submit the Phase 2a protocol to the U.S. Food and Drug Administration following completion of Phase 1. Subject to regulatory feedback, the Company anticipates initiating the Phase 2a study in the second quarter of 2026. Given the oncology-related nature of CIPN, the lack of FDA-approved therapies, and the significant unmet medical need, the Company intends to pursue FDA Fast Track designation for Ketamir-2 as the program advances into later-stage clinical development.
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Pre-Market Stock Movements: Several stocks experienced significant movements in pre-market trading, with Global Interactive Technologies surging 217.7% and Fly-E Group tumbling 25.8% following a reverse stock split announcement.
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MIRA Pharmaceuticals Stock Surge: MIRA Pharmaceuticals' stock price jumped approximately 50.8% to $1.87 after the announcement of Mira-55, a synthetic marijuana analog that provides pain relief comparable to morphine without psychoactive effects.
Regulatory Advancements and Future Prospects: The DEA confirmed that Mira-55 is not a controlled substance, facilitating its clinical development, while the company also progresses with other pain management therapies and an acquisition aimed at enhancing its market position.
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Market Potential and Drug Development: With a focus on the $200 billion market for obesity and smoking-related health issues, MIRA plans to prioritize SKNY-1 as a key asset, especially as it seeks to complete its acquisition of SKNY Pharmaceuticals, while also highlighting the drug's advantages over existing GLP-1 injectables.
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