MIRA News & Events

MIRA Pharmaceuticals announced new preclinical data demonstrating that Mira-55 did not produce cannabinoid-like central nervous system side effects across a comprehensive battery of validated behavioral assays. The observed profile was differentiated from both undefined9-tetrahydrocannabinol, the primary psychoactive component of cannabis, and the CB1 receptor antagonist rimonabant. These findings build on previously reported preclinical data demonstrating that Mira-55 delivered morphine-comparable pain relief in a validated model of inflammatory pain, without opioid-related risks. Collectively, these data support the Company's ongoing efforts to advance Mira-55 toward an Investigational New Drug submission for inflammatory pain. The study, conducted in collaboration with Pharmaseed, evaluated Mira-55 at oral doses of 10, 30, and 100 mg/kg and compared its behavioral effects to THC and rimonabant using established assays commonly employed to assess cannabinoid-related CNS and behavioral effects, including: Hypothermia; Catalepsy; Elevated Plus Maze; Open Field. Key Observations: No cannabinoid-like psychogenic effects were observed at any tested dose of Mira-55; No evidence of sedation, catalepsy, or motor impairment, differentiating Mira-55 from CB1-active compounds such as rimonabant; No anxiogenic effects were observed, in contrast to rimonabant, which demonstrated anxiety-like behavioral changes; In the Elevated Plus Maze, Mira-55 showed a dose-dependent increase in time spent in open arms, consistent with reduced anxiety-like behavior; In Open Field testing, Mira-55-treated groups were comparable to vehicle controls, indicating no detectable adverse behavioral effects. Rimonabant-treated groups demonstrated reduced time spent in the center of the open field, a commonly used indicator of anxiety-like behavior, supporting the sensitivity of the experimental model. The CNS safety findings complement previously reported preclinical efficacy data demonstrating that Mira-55: Reduced pain sensitivity and restored thresholds to near-baseline levels in inflammatory pain models; Demonstrated morphine-comparable analgesic effects in a validated inflammatory pain model; Did not produce sedation or opioid-like adverse effects; Did not induce inflammatory swelling, supporting a differentiated profile versus certain comparator agents. While these findings are based on preclinical models, they support a differentiated pharmacological profile for Mira-55.

MIRA Pharmaceuticals announced completion of dosing in its Phase 1 clinical trial evaluating Ketamir-2, the Company's proprietary selective oral NMDA receptor modulator. The randomized, double-blind, placebo-controlled study enrolled 56 healthy adult volunteers across single ascending dose and multiple ascending dose cohorts. Based on safety data reviewed to date, no serious adverse events or dose-limiting toxicities have been reported at any dose level tested. In addition, no clinically significant dissociative or psychotomimetic effects typically associated with ketamine were observed. Database lock, unblinding, and final audited pharmacokinetic and safety analyses are underway. Phase 1 data have been accepted for presentation at the upcoming American Association for Cancer Research Annual Meeting.

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.