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MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing on Early Clinical Efficacy Demonstration for Neuropathic Pain in 2025
MIAMI, FL / ACCESSWIRE / September 18, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing
About this update from Mira Pharmaceuticals, Inc.
[{"type":"text","content":"MIAMI, FL / ACCESSWIRE / September 18, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing innovative therapies for neurologic and neuropsychiatric disorders, today announced significant progress in the clinical development planning for its novel oral ketamine analog. As part of its strategic development plan, MIRA is prioritizing the early demonstration of clinical efficacy, potentially as early as 2025, through innovative Phase I/II study designs.Drug Product Development InitiatedMIRA has initiated drug product development (capsules) of its novel oral ketamine analog in collaboration with Formulex, a leader in nano-technology-based drug delivery and formulation. This partnership focuses on spray-dry based granulation of Ketamir-2 in capsules for clinical studies, optimizing the formulation for improved oral bioavailability and patient convenience.IND Filing on Schedule for December 2024The company is on track for its Investigational New Drug (IND) filing for its drug candidate Ketamir-2 with the U.S. Food and Drug Administration (FDA) in December 2024. MIRA continues to progress with all required Good Laboratory Practice (GLP) toxicological studies, with data assembly and file preparations well underway.Prioritizing Early Efficacy Signal Detection in Humans for Neuropathic Pain by 2025MIRA is committed to detecting an efficacy signal in humans as early as 2025. Through strategic Phase I/II study designs, the company aims to demonstrate the clinical activity in treating neuropathic pain and potentially other neurologic conditions. This approach emphasizes MIRA's dedication to accelerating the path to clinical efficacy, providing early and robust data that can drive faster decision-making and potentially expedite patient access.MIRA is also conducting ongoing preclinical studies in animal models of Diabetic Neuropathy and Cancer-Induced Neuropathy, with efficacy results expected in late 2024. These studies are critical in refining MIRA's approach and could help identify more targeted indications within specific patient populations. \"Focusing on these specific patient populations increases our chances of demonstrating meaningful clinical benefits,\" said Erez Aminov, Chairman and CEO of MIRA.\"Our primary goal is to demonstrate efficacy in humans as quickly as possibl...