UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01 Other Events
MIRA Pharmaceuticals Achieves 100% Reversal of Neuropathic Pain with Oral Ketamir-2 in Breakthrough Study
MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) announced significant pre-clinical findings from a recent study evaluating its novel oral ketamine analog, Ketamir-2, in a rat model of nerve-ligation induced neuropathic pain. The key results are as follows:
| 1. | Significant Pain Reversal: Low oral doses of Ketamir-2 led to a substantial and significant reversal of neuropathic pain (expressed as mechanical allodynia) for 14 and 22 days following the operation. | |
| 2. | 100% Pain Signal Reversal: At the highest dose, Ketamir-2 achieved a complete normalization of the pain threshold, resulting in a 100% reversal of the neuropathic pain signal. | |
| 3. | Comparison with Oral Ketamine: Oral ketamine, under the same experimental conditions, did not provide significant pain relief, underscoring the superior efficacy of oral Ketamir-2. |
These findings highlight Ketamir-2’s potential as a transformative treatment for neuropathic pain and pave the way for further clinical development.
Cautionary Note Regarding Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements are characterized by future or conditional verbs such as “may,” “will,” “expect,” “intend,” “plans,” “anticipate,” “believe,” “estimate,” “continue” and similar words. Such statements are only predictions and actual events or results may differ materially from those anticipated in these forward-looking statements. You should not place undue reliance on any forward-looking statements. In this report, such forward-looking statements relate to the anticipated benefits of the Company’s preclinical testing results for, and the time for regulatory filings related to, Ketamir-2 or Nor-Ketamir-2. Readers are cautioned that actual future results related to Ketamir-2 or Nor-Ketamir-2 may deviate materially and adversely from the forward-looking statements regarding Ketamir-2 and Nor-Ketamir-2 contained herein. The Company does not assume any obligation to update forward-looking statements as circumstances change, except as required by securities laws. These and other risks concerning the Company’s programs and operations are described in additional detail in Annual Report on Form 10-K for the year ended December 31, 2023 and other SEC filings, which are on file with the SEC at www.sec.gov and the Company’s website at https://www.mirapharmaceuticals.com/investors/sec-filings. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
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 23, 2024 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |