MIRA Pharmaceuticals Achieves 100% Reversal of Neuropathic Pain With Oral Ketamir-2 in Breakthrough Study

Rhea-AI Summary

MIRA Pharmaceuticals (NASDAQ:MIRA) has announced a breakthrough in neuropathic pain treatment. Their novel oral ketamine analog, Ketamir-2, achieved 100% reversal of neuropathic pain in a pre-clinical rat study, outperforming traditional oral ketamine. Key findings include:

- Low doses led to significant pain reversal for 14-22 days post-operation
- Higher doses completely normalized pain thresholds
- Ketamir-2 showed superior efficacy compared to oral ketamine
- Additional studies are underway for cancer-induced depression and neuropathic pain
- Human efficacy could potentially be demonstrated as early as 2025

MIRA is now focusing on scaling production and preparing for clinical trials, positioning Ketamir-2 as a potential game-changer in neuropathic pain treatment.

Positive

• Ketamir-2 achieved 100% reversal of neuropathic pain in pre-clinical rat study
• Ketamir-2 demonstrated superior efficacy compared to traditional oral ketamine
• Low doses of Ketamir-2 led to significant pain reversal for 14-22 days post-operation
• Additional studies are underway for cancer-induced depression and neuropathic pain
• Potential for demonstrating efficacy in humans as early as 2025

Negative

• Results are based on pre-clinical studies, not yet proven in human trials
• Timeline for potential human efficacy demonstration is still a year away (2025)

Medical Research Analyst

This pre-clinical study on Ketamir-2 represents a significant breakthrough in neuropathic pain treatment. The 100% reversal of pain thresholds at higher doses is particularly noteworthy, especially when compared to the ineffectiveness of oral ketamine. This suggests superior efficacy and potential for improved patient outcomes.

The 14 and 22-day pain reversal at lower doses indicates promising durability of effect. However, it's important to note that these are pre-clinical results in rats and human trials may yield different outcomes. The planned studies in cancer-related indications could accelerate the regulatory pathway, potentially bringing this treatment to market sooner.

If Ketamir-2 maintains its efficacy and safety profile in human trials, it could disrupt the current neuropathic pain treatment landscape, offering a more effective, oral alternative to existing therapies.

Financial Analyst

MIRA Pharmaceuticals' breakthrough with Ketamir-2 could significantly impact its market position and financial outlook. The global neuropathic pain market is projected to reach $9.8 billion by 2027, presenting a substantial revenue opportunity if Ketamir-2 proves successful in human trials.

Investors should note that MIRA is still in the pre-clinical stage, with potential human efficacy data not expected until 2025. This timeline suggests a long runway before potential commercialization. However, the company's focus on cancer-related indications could accelerate regulatory approvals and reduce time-to-market.

While promising, it's important to remember that many pre-clinical successes fail to translate to human trials. Investors should carefully consider MIRA's cash position and burn rate to ensure it can fund the necessary clinical trials and potential commercialization efforts.

Pharmaceutical Industry Expert

Ketamir-2's potential as an oral treatment without severe psychotropic side effects is a game-changer in the neuropathic pain space. This could address a significant unmet need in pain management, potentially improving patient compliance and quality of life.

The compound's apparent superiority over oral ketamine is particularly intriguing. If this translates to human trials, Ketamir-2 could leapfrog existing treatments and become a first-line therapy for neuropathic pain. The focus on cancer-related indications is strategically sound, potentially offering a faster path to market.

However, it's important to temper excitement with caution. The journey from pre-clinical to approved drug is long and fraught with challenges. MIRA must navigate complex regulatory pathways, demonstrate safety and efficacy in humans and secure funding for expensive clinical trials. The company's ability to execute on these fronts will be critical to Ketamir-2's success.

Study Highlights Superior Efficacy of Ketamir-2 Over Oral Ketamine, Achieving Full Normalization of Pain Thresholds

MIAMI, FL / ACCESSWIRE / August 26, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a leading pre-clinical-stage pharmaceutical development company, is proud to announce a major breakthrough in the treatment of neuropathic pain. A recent pre-clinical study in rats demonstrated that its novel oral ketamine analog, Ketamir-2, produced a significant reversal of neuropathic pain, induced by nerve ligation, culminating in a 100% normalization of pain thresholds at the highest dose. This effect stands in stark contrast to traditional ketamine, which proved ineffective orally under the same experimental conditions.

The study, conducted at Pharmaseed Ltd, utilized a nerve ligation model to replicate human neuropathic pain and specifically investigates mechanical allodynia. The results were compelling: low oral doses of Ketamir-2 led to a significant reversal of pain for 14 and 22 days following the operation. At higher oral dose, Ketamir-2 achieved complete normalization of the pain threshold, representing a 100% reversal of the neuropathic pain signal. These outcomes underscore Ketamir-2's superior efficacy and highlight its potential as a transformative treatment for neuropathic pain, especially compared to oral ketamine, which did not deliver significant pain relief.

In light of this compelling data, MIRA Pharmaceuticals is conducting additional studies to evaluate Ketamir-2's efficacy in treating cancer-induced depression and neuropathic pain. These studies aim to explore cancer-related indications, which could pave the way for faster regulatory approvals and innovative clinical study designs. MIRA is optimistic that these efforts could demonstrate efficacy in humans as early as 2025.

"The development of Ketamir-2 as an oral treatment for neuropathic pain is a significant milestone not only for MIRA but for the entire field of neuropsychiatric and neurologic disorder therapies," said Erez Aminov, Chairman and CEO of MIRA Pharmaceuticals. "Neuropathic pain is a debilitating condition that imposes an enormous burden on patients, often leaving them with limited and ineffective treatment options. These findings suggest that Ketamir-2 could offer patients a more accessible, safer, and effective treatment option, potentially transforming the standard of care for neuropathic pain."

Dr. Itzchak Angel, Chief Scientific Advisor at MIRA Pharmaceuticals, added, "The ability to administer Ketamir-2 orally without the severe psychotropic side effects commonly associated with ketamine is a remarkable achievement. This positions Ketamir-2 as a pioneering treatment in the realm of neuropathic pain, offering hope to patients who have limited options available."

MIRA Pharmaceuticals continues to advance its research, focusing on scaling production and preparing for the next stages of clinical trials. The company remains committed to bringing safer and more effective treatments to market, with Ketamir-2 at the forefront of its pipeline.

About MIRA Pharmaceuticals

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 potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression, major depressive disorder with suicidal ideation and post-traumatic stress disorder. The U.S. Drug Enforcement Administration's scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations.

In addition, MIRA's novel oral pharmaceutical marijuana analog, MIRA-55, is currently under investigation for treating adult patients suffering from neuropathic pain as well as anxiety and cognitive decline, often associated with early-stage dementia. MIRA-55, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders. The U.S. Drug Enforcement Administration's scientific review of MIRA-55 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations. Additional information about MIRA Pharmaceuticals is available at: www.mirapharmaceuticals.com

Ketamir-2 and MIRA-55 are in early-stage preclinical development. There is no assurance that the products will proceed through development or will receive FDA approval for marketing.

Cautionary Note Regarding Forward-Looking Statements

This press release and the statements of MIRA Pharmaceuticals' (or the "Company") 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 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 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
info@mirapharma.com
(786) 432-9792

SOURCE: Mira Pharmaceuticals, Inc.

View the original press release on accesswire.com

FAQ

What is the main breakthrough announced by MIRA Pharmaceuticals (NASDAQ:MIRA) in their recent study?

MIRA Pharmaceuticals announced that their oral ketamine analog, Ketamir-2, achieved 100% reversal of neuropathic pain in a pre-clinical rat study, outperforming traditional oral ketamine.

How does Ketamir-2 compare to traditional oral ketamine in treating neuropathic pain?

Ketamir-2 showed superior efficacy compared to traditional oral ketamine. While Ketamir-2 achieved significant pain reversal and complete normalization of pain thresholds at higher doses, oral ketamine proved ineffective under the same experimental conditions.

What are the next steps for MIRA Pharmaceuticals (NASDAQ:MIRA) regarding Ketamir-2?

MIRA Pharmaceuticals is conducting additional studies to evaluate Ketamir-2's efficacy in treating cancer-induced depression and neuropathic pain. They are also focusing on scaling production and preparing for the next stages of clinical trials.

When does MIRA Pharmaceuticals (NASDAQ:MIRA) expect to demonstrate Ketamir-2's efficacy in humans?

MIRA Pharmaceuticals is optimistic that they could demonstrate Ketamir-2's efficacy in humans as early as 2025.