MIRA Pharmaceuticals Inc. filed SEC Form 8-K: Other Events
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Item 8.01 Other Events
MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”) today announced that the first subjects have been enrolled in its Phase 1 clinical trial with Ketamir-2, the Company’s novel oral ketamine analog in development for the treatment of neuropathic pain.
The trial is being conducted at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel. This is a randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of Ketamir-2 in healthy adult volunteers. A total of 56 subjects are expected to participate in the study, divided into Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts.
The study follows favorable preclinical data demonstrating that Ketamir-2 achieved superior efficacy in validated neuropathic pain models compared to FDA-approved treatments such as pregabalin and gabapentin. The compound also demonstrated a favorable safety profile, high oral bioavailability, and no interaction with P-glycoprotein (P-gp), supporting its potential for improved brain penetration.
The Company anticipates completing the Phase 1 study by the fourth quarter of 2025 and initiating a Phase 2a clinical trial in diabetic neuropathic pain by year-end. First human efficacy data are expected in the first half of 2026.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MIRA PHARMACEUTICALS, INC. | |||
| Dated: | April 1, 2025 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | ||
| Title: | Chief Executive Officer | ||