MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing on Early Clinical Efficacy Demonstration for Neuropathic Pain in 2025

MIAMI, FL / ACCESSWIRE / September 18, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing innovative therapies for neurologic and neuropsychiatric disorders, today announced significant progress in the clinical development planning for its novel oral ketamine analog. As part of its strategic development plan, MIRA is prioritizing the early demonstration of clinical efficacy, potentially as early as 2025, through innovative Phase I/II study designs.

Drug Product Development Initiated
MIRA has initiated drug product development (capsules) of its novel oral ketamine analog in collaboration with Formulex, a leader in nano-technology-based drug delivery and formulation. This partnership focuses on spray-dry based granulation of Ketamir-2 in capsules for clinical studies, optimizing the formulation for improved oral bioavailability and patient convenience.

IND Filing on Schedule for December 2024
The company is on track for its Investigational New Drug (IND) filing for its drug candidate Ketamir-2 with the U.S. Food and Drug Administration (FDA) in December 2024. MIRA continues to progress with all required Good Laboratory Practice (GLP) toxicological studies, with data assembly and file preparations well underway.

Prioritizing Early Efficacy Signal Detection in Humans for Neuropathic Pain by 2025
MIRA is committed to detecting an efficacy signal in humans as early as 2025. Through strategic Phase I/II study designs, the company aims to demonstrate the clinical activity in treating neuropathic pain and potentially other neurologic conditions. This approach emphasizes MIRA's dedication to accelerating the path to clinical efficacy, providing early and robust data that can drive faster decision-making and potentially expedite patient access.

MIRA is also conducting ongoing preclinical studies in animal models of Diabetic Neuropathy and Cancer-Induced Neuropathy, with efficacy results expected in late 2024. These studies are critical in refining MIRA's approach and could help identify more targeted indications within specific patient populations. "Focusing on these specific patient populations increases our chances of demonstrating meaningful clinical benefits," said Erez Aminov, Chairman and CEO of MIRA.

"Our primary goal is to demonstrate efficacy in humans as quickly as possible," added Erez Aminov. "By implementing specific study designs and leveraging our ongoing preclinical research, we aim to gather early evidence of clinical benefits, positioning our treatment as a transformative option for neuropathic pain."

Phase I Clinical Development Plan Finalized
MIRA has completed the design of its Phase I clinical trial, set to begin in early Q1 2025. This trial will assess safety, tolerability, and pharmacokinetics in humans, laying the groundwork for subsequent efficacy studies. MIRA is also collaborating with leading international academic research institutions to further refine and enhance its clinical development strategy.

"We are excited to move smoothly forward with our IND-enabling pre-clinical studies towards Phase I trials, which are designed to provide critical insights into the safety and pharmacokinetic profile of our candidate," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "This trial is a pivotal step in our journey to bring novel treatment options for neuropathic pain to patients, and we are committed to executing it with the highest scientific and regulatory standards."

Strengthening Regulatory and Clinical Strategy
To bolster its clinical and regulatory approach, MIRA has appointed an experienced consultant who brings extensive expertise from academia and regulatory bodies, including the FDA. This addition underscores the company's commitment to meeting the highest standards in clinical development and regulatory compliance, ensuring a smooth and efficient process.

Looking Ahead
In addition to the planned Phase I clinical trial in Q1 2025, MIRA is exploring additional indications in the mental health space, including Major Depressive Disorder with Suicidal Ideation (MDD-SI), Treatment-Resistant Depression (TRD), and Post-Traumatic Stress Disorder (PTSD). MIRA aims to broaden the therapeutic applications of its platform to address these unmet needs, with the potential to initiate a depression IND as early as next year. This initiative reflects our commitment to advancing treatments that improve patient outcomes and quality of life.

About MIRA Pharmaceuticals, Inc
MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. MIRA holds the exclusive U.S., Canadian, and Mexican rights for Ketamir-2, a novel, patent-pending oral ketamine analog under investigation to treat neuropathic pain (NP), treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDD-SI), and post-traumatic stress disorder (PTSD).

MIRA's novel oral pharmaceutical marijuana analog, MIRA-55, is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. If approved by the FDA, MIRA-55 could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders.

The U.S. Drug Enforcement Administration's scientific review concluded that both Ketamir-2 and MIRA-55 would not be considered controlled substances or listed chemicals under the Controlled Substances Act and its governing regulations.

Additional information about MIRA Pharmaceuticals is available at 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 http://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
info@mirapharma.com
(786) 432-9792

SOURCE: Mira Pharamaceuticals, Inc.