MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing On Early Clinical Efficacy Demonstration For Neuropathic Pain In 2025
Miami, Florida
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September 19, 2024 09:00 AM Eastern Daylight Time
By Meg Flippin, Benzinga
MIRA Pharmaceuticals (NASDAQ: MIRA), the pre-clinical-stage pharmaceutical company focused on transforming the treatment of neuropathic pain and mental health disorders through scientific research and technological advancements, is making progress in its clinical development planning for Ketamir-2, its novel oral ketamine analog.
So much so that the company said that, as part of its strategic development plan, it’s prioritizing early demonstration of Ketamir-2’s clinical efficacy. That could come as early as 2025 through innovative phase 1/2 study designs. What’s more, the company said it's on track for Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA) in December 2024.
"Our primary goal is to demonstrate efficacy in humans as quickly as possible," says MIRA Pharmaceuticals chairperson and CEO 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."
To bolster its approach to clinical and regulatory approval, MIRA said it brought on a consultant with expertise in navigating academia and regulatory bodies, including the Federal Drug Administration. The company said this addition demonstrates that it is serious about meeting the highest standards in clinical development and regulatory compliance.
Ketamir-2’s Approach To Fighting Neuropathic Pain and Depression
Ketamir-2 is an oral ketamine analog designed to be taken as a pill. It is being investigated for the treatment of neuropathic pain, treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDDSI) and PTSD. Unlike traditional ketamine, which requires intravenous administration, posing accessibility and safety challenges, Ketamir-2 could potentially simplify and improve the treatment experience.
The company is exploring Ketamir-2's potential efficacy in treating chemotherapy-induced depression, cancer-related neuropathic pain and diabetic neuropathy. These conditions often have limited treatment options and significant patient populations needing effective therapies. Neuropathic pain alone is a big market, poised to reach over $14 billion by 2034, growing at a CAGR of 5.7% from now until then. Driving demand for drugs to relieve pain is an aging population in the U.S. and an increase in chronic diseases.
Collaborating To Speed Time To Market
To get testing underway, MIRA Pharmaceuticals said it is collaborating with Formulex, a nano-technology-based drug delivery company, to develop ways to deliver Ketamir-2. The two focus on a spray-dry based granulation of Ketamir-2 in capsules for clinical studies, optimizing the formulation for improved oral bioavailability and patient convenience. A deterrent to more people using ketamine to treat mental health issues and chronic pain is the delivery. Traditional ketamine treatment for depression requires a Risk Evaluation and Mitigation Strategy (REMS) protocol due to its potential for abuse and severe side effects. This involves strict regulations, including requiring intravenous administration under medical supervision, making it less accessible and more costly for patients.
In contrast, Ketamir-2, as an oral formulation, aims to provide a more convenient and less intimidating treatment option. By reducing the need for medical supervision and hospital visits, MIRA Pharmaceuticals says Ketamir-2 could enhance patient compliance and decrease overall treatment costs.
Phase I Trial Kicking Off Soon
Through the phase I/II study designs MIRA is focused on demonstrating the clinical activity in treating neuropathic pain and potentially other neurologic conditions. The idea is to gather data that can drive faster decision-making and potentially expedite patient access, the company said. The phase 1 clinical trial is slated to kick off in the first quarter of 2025 and will be used to assess safety, tolerability and pharmacokinetics in humans. MIRA says that lays the groundwork for subsequent efficacy studies. MIRA collaborates with international academic research institutes to 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. Angel, chief scientific advisor at MIRA Pharmaceuticals. “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.”
Featured photo by Towfiqu barbhuiya on Unsplash.
MIRA Pharmaceuticals, Inc., is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. We hold exclusive license rights in the U.S., Canada and Mexico for Ketamir-2, a novel, patent pending oral ketamine analog under pre-clinical investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression (“TRD”), major depressive disorder with suicidal ideation (MDSI), and potentially post-traumatic stress disorder (“PTSD”).
The statements of the Company's management related thereto contains "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 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 and MIRA-55. Any forward-looking statements 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 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.
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