MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) has announced significant progress in the clinical development of Ketamir-2, a novel oral ketamine analog, aimed at treating neuropathic pain and potentially other neurologic conditions. The company is prioritizing early demonstration of clinical efficacy, potentially as early as 2025, through innovative Phase I/II study designs.
Drug Product Development
MIRA has initiated drug product development of Ketamir-2 capsules 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
The company is on track for its Investigational New Drug (IND) filing for 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
MIRA 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. Ongoing preclinical studies in animal models of Diabetic Neuropathy and Cancer-Induced Neuropathy are expected to provide efficacy results in late 2024, refining MIRA's approach and potentially identifying 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.
Phase I Clinical Development Plan
MIRA has completed the design of its Phase I clinical trial, set to begin in early Q1 2025. This trial will assess safety, tolerability, and pharmacokinetics in humans, laying the groundwork for subsequent efficacy studies. MIRA is also collaborating with leading international academic research institutions to further refine and enhance its clinical development strategy. "This trial is a pivotal step in our journey to bring novel treatment options for neuropathic pain to patients, and we are committed to executing it with the highest scientific and regulatory standards," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA.
Strengthening Regulatory and Clinical Strategy
To bolster its clinical and regulatory approach, MIRA has appointed an experienced consultant who brings extensive expertise from academia and regulatory bodies, including the FDA. This addition underscores the company's commitment to meeting the highest standards in clinical development and regulatory compliance, ensuring a smooth and efficient process.
Exploring Additional Indications
In addition to the planned Phase I clinical trial in Q1 2025, MIRA is exploring additional indications in the mental health space, including Major Depressive Disorder with Suicidal Ideation (MDD-SI), Treatment-Resistant Depression (TRD), and Post-Traumatic Stress Disorder (PTSD). MIRA aims to broaden the therapeutic applications of its platform to address these unmet needs, with the potential to initiate a depression IND as early as next year.
