On Tuesday, MIRA Pharmaceuticals, Inc. 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:

• Cardiovascular Safety in Dogs: No adverse effects were noted at therapeutic doses.
• CNS Assessment in Rats: No significant CNS changes were observed at therapeutic dose levels, confirming a favorable safety profile. Effects in high-dose groups were limited, transient, and non-disruptive.
• Respiratory Safety in Rats: No respiratory-related effects were noted across all tested doses.
• 14-Day Toxicology in Dogs: Ketamir-2 was well-tolerated at daily doses up to 200 mg/kg, with no observed adverse effects. This dose established the No Observed Adverse Effect Level (NOAEL).
• Ames Test: Ketamir-2 was confirmed to be non-mutagenic, further supporting its safety profile.

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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