Core Viewpoint - MIRA Pharmaceuticals is advancing the development of Ketamir-2, an oral ketamine analog, for the treatment of PTSD, depression, and neuropathic pain, with preclinical studies underway and plans for human testing in 2025 [1][2][9]. Group 1: Preclinical Studies and Development - MIRA has initiated preclinical trials in collaboration with Pharmaseed to evaluate Ketamir-2's efficacy against ketamine in a rat model of severe PTSD, focusing on chronic stress and fear memory processing [3]. - A head-to-head study with Biotrial will assess the locomotor activity effects of Ketamir-2 compared to ketamine, providing insights into its pharmacodynamics and potential side effects [4]. - MIRA has also started 7-day toxicology studies in rats and dogs with Frontage Laboratories, which are essential for ensuring the safety and efficacy of Ketamir-2 before human trials [5]. Group 2: Manufacturing and Regulatory Progress - Significant advancements have been made in the manufacturing process of Ketamir-2, optimizing the synthetic process and reducing production costs, which is crucial for scaling up under Good Manufacturing Practices (GMP) [6]. - MIRA anticipates submitting an Investigational New Drug Application (IND) to the FDA by the end of this year, contingent on positive preclinical results [2]. Group 3: Market Potential and Therapeutic Applications - PTSD affects approximately 8 million adults annually in the U.S., with current treatments often providing limited relief, highlighting the potential market for Ketamir-2 as a safer and more effective alternative [7]. - The U.S. market for PTSD treatments is projected to reach $26 billion by 2031, indicating significant growth potential for Ketamir-2 [9]. - MIRA is exploring collaborations with research centers to study Ketamir-2's efficacy in treating cancer pain, which could broaden its therapeutic applications [8]. Group 4: Management Insights - The management emphasizes the importance of these preclinical trials in addressing severe mental health disorders and neuropathic pain, with a focus on the financial impact of treatment-resistant depression in the U.S., estimated at $92.7 billion annually [9]. - The unique properties of Ketamir-2, including high oral bioavailability and lack of mu opioid interaction, position it as a promising option for rapid relief from depression in a home setting [9].
Mira Pharmaceuticals Advances Preclinical Trials Towards an IND Submission This Year for Ketamir-2, a Differentiated Oral Ketamine Analog