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Item 8.01 Other Events
MIRA Pharmaceuticals Announces Completion of Phase 1 Single Ascending Dose for Oral Ketamir-2 with No Safety Concerns, Advances to Multiple Ascending Dose Stage
Following FDA IND clearance for neuropathic pain, the Company is preparing to initiate its U.S. Phase 2a trial in Q4 2025
On August 19, 2025, MIRA Pharmaceuticals, Inc. (the “Company”) announced the completion of the Single Ascending Dose (“SAD”) portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2 in healthy adult volunteers.
The trial is being conducted at the Hadassah Clinical Research Center in Israel under the direction of Principal Investigator Prof. Yoseph Caraco.
The SAD portion of the trial enrolled 32 participants across four single dose cohorts ranging from 50 mg to 600 mg of Ketamir-2.
Dosing decisions were overseen by an independent Safety Steering Committee, which reviewed blinded emerging safety and tolerability data before advancing to next higher dose levels.
Safety monitoring also included the Columbia-Suicide Severity Rating Scale (C-SSRS), Bowdle Visual Analogue Scale (VAS), and Ketamine Side Effect Tool (KSET) questionnaires.
Based on blinded safety data available to date in the SAD portion, no severe or clinically significant adverse effects have been observed at any dose level.
The Company is proceeding to the Multiple Ascending Dose (“MAD”) portion of the trial, the final stage of Phase 1, which will evaluate three cohorts receiving daily oral doses of 150 mg, 300 mg, or 600 mg for five consecutive days in up to 24 participants.
The trial is designed to evaluate the safety, tolerability, and pharmacokinetics of repeated administration of Ketamir-2 in healthy adult volunteers.
The Company has previously received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for Ketamir-2 in neuropathic pain and expects to initiate a U.S. Phase 2a clinical trial in Q4 2025, subject to ongoing results and regulatory review.
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: August 19, 2025 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |