Company: MIRA
Filing Date: 2025-08-19
Form Type: 8-K
Source: 0001641172-25-024731
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Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-08-19
Form: 8-K
Item: Item 8.01
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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