Company: MIRA
Filing Date: 2025-10-23
Form Type: 8-K
Source: 0001493152-25-019065
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Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-10-23
Form: 8-K
Item: Item 8.01
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Item
8.01 Other Events

MIRA
Pharmaceuticals Initiates Multiple Ascending Dose (MAD) Phase 1 Study of Oral Ketamir-2 and Selects Chemotherapy-Induced Neuropathic
Pain as Lead Phase 2a Indication

Advancing
toward Phase 2a clinical evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast
Track consideration

MIRA
Pharmaceuticals, Inc. (NASDAQ: MIRA) (“ MIRA” or the “ Company”) announced that it has initiated the multiple ascending
dose (MAD) portion of its ongoing Phase 1 clinical trial, evaluating its lead oral candidate, Ketamir-2, in healthy volunteers. The Company
also announced that it has selected chemotherapy-induced peripheral neuropathy (CIPN) as the lead indication for its planned Phase 2a
clinical evaluation.

This
milestone follows the completion of dosing in the single ascending dose (SAD) portion of the study. According to data reviewed to date,
no serious or dose-limiting adverse events were observed, and no clinically significant safety concerns have been reported. Comprehensive
pharmacokinetic analyses will be performed following unblinding to further characterize Ketamir-2’s absorption and half-life profile.
The ongoing randomized, double-blind, placebo-controlled Phase 1 study is evaluating single and multiple oral doses of Ketamir-2 to assess
its safety, tolerability, and pharmacokinetics in healthy volunteers. The MAD portion includes three cohorts of repeat daily oral dosing
ranging from 150 mg to 600 mg for five days, building on the safety and PK data from the SAD phase.

Ketamir-2’s
advancement is supported by a growing body of preclinical and peer-reviewed research demonstrating activity in validated neuropathic
pain models. In these studies, Ketamir-2 outperformed ketamine, gabapentin, and pregabalin in reducing pain behaviors and restoring sensory
function across several models of neuropathic pain. In the paclitaxel chemotherapy-induced neuropathy model, Ketamir-2 produced near
complete normalization of pain sensitivity and demonstrated greater efficacy than gabapentin, an FDA-approved standard for neuropathic
pain.

Chemotherapy-induced
peripheral neuropathy (CIPN) is a painful nerve damage condition caused by certain chemotherapy drugs that can result in persistent pain,
tingling, numb