MIRA Pharmaceuticals has made significant strides by completing dosing in the Phase I clinical trial of its innovative compound, Ketamir-2. This trial is pivotal for evaluating the safety, tolerability, and pharmacokinetics of Ketamir-2, a selective oral N-methyl-D-aspartate (NMDA) receptor modulator.
Study Location and Framework
The trial took place at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel. This setting provided a robust environment for conducting clinical evaluations of new pharmaceutical entities.
Key Characteristics of Ketamir-2
Ketamir-2 is an orally administered new molecular entity characterized by predictable pharmacokinetics and a non-scheduled status after thorough review by the US Drug Enforcement Administration. These attributes are essential for establishing its potential as a viable treatment option.
Trial Design and Participant Involvement
The Phase I trial employed a double-blind, placebo-controlled, randomized design, enrolling 56 healthy adult participants. The study assessed both single and multiple ascending dose cohorts, allowing for comprehensive safety and efficacy evaluations.
Safety and Tolerability Findings
Preliminary safety data indicate an encouraging profile, with no serious adverse events or dose-limiting toxicities reported at any dose level throughout the trial. Furthermore, the compound did not produce clinically significant dissociative effects, which are often associated with ketamine.
Evaluation of Central Nervous System Safety
To assess central nervous system safety, the trial utilized tools such as the Bowdle visual analogue scale, the ketamine side effect tool, and the Columbia-suicide severity rating scale. These assessments aimed to evaluate any perceptual, mood-related, or dissociative effects resulting from Ketamir-2.
Future Development Plans
MIRA Pharmaceuticals plans to submit the Phase IIa clinical study protocol and necessary documentation to the US Food and Drug Administration (FDA) in the first half of 2026. This next phase aims to target patients suffering from moderate to severe chemotherapy-induced peripheral neuropathy (CIPN), a condition with a significant unmet medical need.
Statement from Leadership
Erez Aminov, chairman and CEO of MIRA Pharmaceuticals, remarked on the importance of completing Phase I dosing. He emphasized that this milestone not only represents a critical inflection point for the company but also reflects their objective to develop a selective oral NMDA modulator with a differentiated safety profile suitable for chronic use.
Conclusion
The completion of the Phase I trial for Ketamir-2 marks a promising step forward for MIRA Pharmaceuticals. With favorable findings and a clear regulatory pathway, the company is well-positioned to advance its research into clinical efficacy and address a pressing healthcare challenge. As they move into the next phase, the potential impact of Ketamir-2 on patient care is considerable.
- Key Takeaways:
- MIRA Pharmaceuticals has completed dosing in the Phase I trial of Ketamir-2.
- The study demonstrated a favorable safety profile with no serious adverse effects reported.
- Future plans include a Phase IIa clinical trial targeting chemotherapy-induced peripheral neuropathy.
- The innovative compound showcases predictable pharmacokinetics and a non-scheduled status.
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