On Tuesday, MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) said it completed the current Good Laboratory Practice preclinical safety program for Ketamir-2, a novel oral ketamine analog.
The results confirm no adverse findings, clearing a critical milestone as the company progresses toward submitting its Investigational New Drug (IND) application by year-end 2024.
Also Read: MIRA Pharmaceuticals’ Formulated Shows Greater Efficacy Than FDA-Approved Drug For Chemo-Induced Neuropathic Pain
The company says that by demonstrating Ketamir-2’s robust safety profile in comprehensive preclinical studies, MIRA has significantly de-risked this critical aspect of drug development.
This milestone positions the company for a smoother regulatory pathway, potentially increasing the likelihood of successful clinical outcomes.
Highlights of Preclinical Findings:
The Phase 1 trial, set to begin in the first quarter of 2025, is designed to gather critical insights into the safety, tolerability, pharmacokinetics, and pharmacodynamics of Ketamir-2 in healthy subjects.
The trial will include a robust battery of pain tests to evaluate the drug’s effects on neuropathic pain and psychosis.
These evaluations are expected to provide data by Q2 2025, helping to understand how Ketamir-2 affects pain in humans prior to initiating Phase 2a trials in patients.
Building on the Phase 1 findings, MIRA plans to initiate a Phase 2a proof-of-concept study in Q4 2025, focusing on patients with neuropathic pain. Proof-of-concept results are anticipated by year-end 2025.
Price Action: At last check on Tuesday, MIRA stock was down 1.63% to $1.21 during the premarket session.
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This article EXCLUSIVE: MIRA Pharmaceuticals Validates Ketamir-2's Safety Profile, Paving Way For Human Trials In Neuropathic Pain originally appeared on Benzinga.com
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