MIRA Pharmaceuticals Initiates Final Cohort of Ketamir-2 Phase 1 Clinical Study as Company Prepares for Phase 2a Study

About this update from Mira Pharmaceuticals, Inc.

[{"type":"text","content":"Company to Participate in BIO Partnering Summit and Present Phase 1 Ketamir-2 Data at American Association for Cancer Research (AACR)Annual Meeting","length":147,"tagName":"p"},{"type":"text","content":"MIAMI, FLORIDA / ACCESS Newswire / February 3, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neuropathic and inflammation-driven pain conditions, metabolic disorders, and oncology-related indications, today announced that it has initiated dosing in the final cohort of its Phase 1 multiple ascending dose (MAD) clinical trial evaluating Ketamir-2, its lead oral NMDA receptor antagonist.","length":515,"tagName":"p"},{"type":"text","content":"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.","length":235,"tagName":"p"},{"type":"text","content":"Phase 1 Progress and Phase 2a Development Plans","length":47,"tagName":"p"},{"type":"text","content":"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.","length":322,"tagName":"p"},{"type":"text","content":"MIRA is actively finalizing its Phase 2a proof-of-concept study in chemotherapy-induced peripheral neuropathy (CIPN), including clinical site selection, and plans to submit the Phase 2a protocol to the U.S. Food and Drug Administration (FDA) following completion of Phase 1. Subject to regulatory feedback, the Company anticipates initiating the Phase 2a study in the second quarter of 2026.","length":391,"tagName":"p"},{"type":"text","content":"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.","length":252,"tagName":"p"},{"type":"text","content":"Chemotherapy-Induced Peripheral Neuropathy Represents a Significant Un...

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