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Item 8.01 Other Events
MIRA Reveals Innovative Phase I/IIa Protocol Design and Selection of Clinical Trial Site
MIRA Pharmaceuticals, Inc. (the “Company”, “MIRA”), a preclinical-stage pharmaceutical company, is pleased to announce the selection of The Centre for Human Drug Research (CHDR) in Leiden, The Netherlands, as the site for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine analog. Recruitment for the trial is set to begin in Q1 2025, with initial safety and efficacy results from the Phase I study in healthy subjects expected in the second half of 2025. The Phase IIa study, planned to start in Q4 2025, will focus on diabetic neuropathy patients, with initial human efficacy results anticipated in the first half of 2026.
The trial leverages CHDR’s proprietary PainCart® technology, a validated tool for measuring pain response. This advanced technology allows MIRA to assess early signs of efficacy in healthy subjects during Phase I, a capability that is typically unavailable at this stage of development. Psychoactivity assessments will also be conducted separately as part of an independent evaluation. The unique capabilities of PainCart® was a key reason for selecting CHDR as the trial site, allowing MIRA to gain valuable insights into Ketamir-2’s potential for pain management earlier in the clinical process together with information about safety and pharmacokinetics.
Cautionary Note Regarding Forward-Looking Statements
This press release and the statements of MIRA Pharmaceuticals’ (or the “Company”) management related thereto contain “forward-looking statements,” which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the study results described herein as well as the timing for the Company’s other preclinical studies and the filing of an IND for Ketamir-2. Any forward-looking statements in this press release are based on the Company’s current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company’s control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company’s programs and operations are described in additional detail in the 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 PHARMACUTICALS, INC. | ||
| Dated: November 19, 2024 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |