MIRA Pharmaceuticals Enrolls First Subjects in Phase 1 Clinical Trial of Ketamir-2 for Neuropathic Pain

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[{"type":"text","content":"MIAMI, FLORIDA / ACCESS Newswire / April 1, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company developing breakthrough therapeutics for neurologic and neuropsychiatric disorders, today announced the enrollment of the first subjects in its Phase 1 clinical trial of Ketamir-2, a novel oral ketamine analog in development for the treatment of neuropathic pain.","length":396,"tagName":"p"},{"type":"text","content":"The Phase 1 trial is being conducted at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel. This randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of Ketamir-2 in healthy adult volunteers. A total of 56 subjects will be enrolled across both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts.","length":399,"tagName":"p"},{"type":"text","content":"This important clinical milestone follows compelling preclinical data, where Ketamir-2 demonstrated superior efficacy compared to FDA-approved neuropathic pain treatments, including pregabalin and gabapentin. It also showed a strong safety profile and oral bioavailability, without the dissociative or psychedelic effects commonly associated with ketamine. Additionally, Ketamir-2 is not a substrate for P-glycoprotein (P-gp), which supports its ability to efficiently cross the blood-brain barrier-a critical factor in treating central nervous system disorders.","length":562,"tagName":"p"},{"type":"text","content":""The Phase 1 trial is progressing smoothly and according to plan," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "Ketamir-2's unique mechanism and pharmacological profile make it a highly promising candidate for neuropathic pain. If successful, it could represent a safer, non-addictive alternative to opioids and a more effective option than current standard treatments like pregabalin and gabapentin."","length":439,"tagName":"p"},{"type":"text","content":"Phase 1 Completion and Clinical Timeline","length":40,"tagName":"p"},{"type":"text","content":"MIRA anticipates completing the Phase 1 study by Q4 2025. The Company plans to initiate a Phase 2a trial in patients with diabetic neuropathic pain by year-end, with first human efficacy data expected in the first half of 2026.","length":227,"tagName":"p"...

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