Mira Pharmaceuticals completes Phase 1 SAD portion for oral Ketamir-2

MIRA Pharmaceuticals (MIRA) announced the completion of the Single Ascending Dose portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2. The study, conducted at the Hadassah Clinical Research Center in Israel under the direction of Principal Investigator Prof. Yoseph Caraco, demonstrated a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed to date. The study- “A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Centre Study of Single and Repeated Dosing of Ascending Doses, to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects”-is designed to establish the safety, tolerability, and pharmacokinetics of Ketamir-2 in healthy adult volunteers. Design: Single-center, randomized, double-blind, placebo-controlled SAD/MAD with sentinel dosing and Safety Steering Committee reviews between cohorts. SAD completed: Four cohorts; 32 participants treated. Safety monitoring: Extensive central nervous system safety assessments were performed using well-validated clinical research tools: Columbia-Suicide Severity Rating Scale – screens for suicidal ideation or behavior, supporting early detection of potential mood or psychiatric changes. Bowdle Visual Analogue Scale – measures possible psychedelic or dissociative effects sometimes seen with ketamine and related compounds. Ketamine Side Effect Tool – tracks a broad range of known ketamine-related side effects over time, including sensory, cognitive, and mood changes. These tools provided multiple, complementary layers of safety evaluation to help detect even subtle CNS effects throughout the trial. Status: To date, no severe or clinically significant adverse effects have been observed at any dose level in the SAD portion of the study. While the study remains ongoing and blinded, it is worth noting that, across the pharmaceutical industry as a whole, approximately one-third of investigational drugs fail during Phase 1 due to safety concerns. These interim observations provide encouraging context as MIRA advances Ketamir-2 through the next stage of clinical evaluation, consistent with the Company’s mission to prioritize safety in every step of development. The Company is advancing to the Multiple Ascending Dose (MAD) portion, which will evaluate three cohorts receiving daily oral doses of 150 mg, 300 mg, or 600 mg for five consecutive days in up to 24 participants.