The China Mail - MIRA Reveals Innovative Phase I/IIa Protocol Design and Selection of Clinical Trial Site

Backed by a Strong Balance Sheet, MIRA Accelerates Toward Becoming a Clinical-Stage Company and Advancing Breakthroughs in Pain and Depression Treatment

MIRA Pharmaceuticals, Inc. (NASDAQ: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.

Innovative Study Design Focused on Early Proof-of-Concept Data

The Phase I/IIa trial is structured as a randomized, double-blind, placebo-controlled study conducted in two parts:

Phase I: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts in healthy subjects will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics. PainCart will be used to measure pain response, providing robust early efficacy data, while psychoactivity will be assessed separately through dedicated testing.

Phase IIa: The Proof of Concept (POC) study, planned to begin in the last quarter of 2025, will focus on diabetic neuropathy patients, generating efficacy data in a patient population to validate the Phase I findings.

"This innovative protocol is designed to deliver early, robust proof-of-concept data, advancing Ketamir-2's clinical development and positioning us for strategic partnerships or an M&A opportunity," said Erez Aminov, CEO and Chairman of MIRA Pharmaceuticals.

Dr. Itzchak Angel, Chief Scientific Advisor at MIRA Pharmaceuticals, stated, "the selection of CHDR and the incorporation of PainCart technology in this trial represent a significant step forward in Ketamir-2's development. The ability to gather early efficacy data in healthy subjects provides an invaluable opportunity to optimize the drug's potential and streamline its progress toward addressing the unmet needs in pain management. Our goal is to establish Ketamir-2 as a pioneering therapy in this space."

Ongoing Preclinical and Manufacturing Updates

MIRA continues to make significant progress in its broader pipeline. Preclinical studies for diabetic neuropathy and PTSD are ongoing, and the Company remains on track to complete its IND submission by year-end. Capsule manufacturing for the Phase I/IIa trial is also in its final stages, ensuring readiness for patient dosing in early 2025.

The Company is actively pursuing non-dilutive grant opportunities to support its research programs and is preparing multiple scientific journal publications detailing Ketamir-2's mechanism of action, preclinical results, and potential therapeutic applications. These efforts aim to enhance scientific understanding and attract additional resources for development.

Strong Financial Position and Strategic Focus

MIRA believes that it has a healthy balance sheet, and accordingly, is well-positioned to achieve its strategic goals without reliance on unfavorable financing deals. "We are committed to diligently pursuing strategic partnerships and ensuring the successful development of Ketamir-2 while exploring its potential for broader market applications," added Aminov.

Superior Efficacy and Safety: A Groundbreaking Therapy

Ketamir-2 has consistently outperformed several well-known drugs like pregabalin and gabapentin in preclinical studies, demonstrating superior efficacy and a strong safety profile. The drug is designed to address an urgent unmet need for safe, effective, and non-addictive treatments for pain and depression.

"Our focus on developing a non-addictive, safe, and highly effective solution for pain and depression addresses an urgent unmet need," said Aminov. "With no side effects observed to date, Ketamir-2 represents a promising breakthrough in pain management."

Looking Ahead

As MIRA transitions into a clinical-stage company, the team remains dedicated to advancing Ketamir-2 through rigorous clinical trials, building strategic partnerships, and exploring additional indications to maximize its therapeutic potential. MIRA will aim to achieve significant milestones in the months ahead as it continues to generate innovation in pain and depression treatment.

For more information, please visit www.mirapharmaceuticals.com

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.

Contact Information

Helga Moya
[email protected]
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

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