Mira Pharmaceuticals announces topline results from Phase 1 SAD study

MIRA Pharmaceuticals (MIRA) announced topline results from the single ascending dose portion of its ongoing Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics of its lead oral candidate, Ketamir-2, in healthy volunteers. The randomized, placebo-controlled study enrolled 32 healthy adult participants across four escalating oral dose cohorts. The primary endpoints were safety, tolerability, and PK characterization. Key Pharmacokinetic Findings: Dose-proportional increases in exposure were observed across all dose levels tested. Median time to maximum plasma concentration reached within 1-2 hours, consistent across cohorts, confirming rapid and predictable absorption. Terminal half-life of Ketamir-2 ranged from 2-5 hours, while its primary active metabolite, nor-Ketamir, demonstrated a longer half-life of 6.5-8.5 hours. This favorable duration of action supports convenient once-daily dosing and may contribute to sustained therapeutic benefit. This contrasts with oral ketamine, which is characterized by erratic absorption and a much shorter half-life, limiting its clinical use in chronic treatment. The predictable PK profile of Ketamir-2 supports convenient once-daily dosing for patients with neuropathic pain and potentially other CNS conditions. Safety and Tolerability: Ketamir-2 was generally safe and well tolerated across all four cohorts; No dose-limiting toxicities or serious adverse events were observed; Treatment-emergent adverse events were transient and resolved without intervention; In addition to routine safety assessments, CNS effects were carefully monitored using validated tools. Across all SAD cohorts, Ketamir-2no clinically significant adverse effects observed. Based on the data, MIRA is initiating the multiple ascending dose portion of the Phase 1 study in healthy volunteers, to be followed by a Phase 2a trial in patients with neuropathic pain.