Mira Pharmaceuticals Advances Preclinical Trials Towards an IND Submission This Year for Ketamir-2, a Differentiated Oral Ketamine Analog
Mira Pharmaceuticals has announced significant advancements in preclinical trials for Ketamir-2, an oral ketamine analog aimed at treating PTSD, depression, and neuropathic pain, including cancer pain. The company plans to submit an Investigational New Drug (IND) application to the FDA by year-end, aiming for human trials in 2025.
In collaboration with Pharmaseed, MIRA is testing Ketamir-2's efficacy in severe PTSD using rat models. Another study with Biotrial will evaluate the drug's locomotor effects in mice. MIRA has also initiated toxicological studies with Frontage Laboratories and improved the manufacturing process to reduce costs.
The potential market for Ketamir-2 is substantial, with PTSD affecting 8 million adults annually in the U.S. and the market for PTSD treatments projected to reach $26 billion by 2031.
- Initiation of preclinical trials for Ketamir-2 aimed at treating PTSD, depression, and neuropathic pain.
- Collaboration with Pharmaseed to test Ketamir-2's efficacy for severe PTSD in rat models.
- Partnership with Biotrial to study Ketamir-2's locomotor effects in mice.
- Initiation of 7-day toxicology studies with Frontage Laboratories.
- Optimized manufacturing process for Ketamir-2, reducing production costs.
- Potential market for PTSD treatments projected to reach $26 billion by 2031.
- High oral bioavailability and lack of mu opioid interaction, offering a safer option for home-based treatment.
- The drug is still in preclinical stages, with human trials not expected until 2025.
- Efficacy and safety of Ketamir-2 are still unproven in human subjects.
- Significant financial commitment required for ongoing trials and eventual FDA approval.
Insights
The advancements in preclinical trials for Ketamir-2 by Mira Pharmaceuticals present a considerable development in the treatment of PTSD, depression and neuropathic pain. The potential for Ketamir-2 to be an oral ketamine analog allowing at-home treatment is noteworthy. Current ketamine treatments require administration in controlled settings due to their mode of delivery and associated side effects. The pursuit of an Investigational New Drug (IND) application underscores the importance of this compound.
Ketamir-2's differentiation includes higher oral bioavailability and no mu opioid interaction, which could lead to a safer profile compared to traditional ketamine. This is important for outpatient settings, where safety and ease of use are paramount. The effectiveness of ketamine in rapid and sustained reduction of PTSD symptoms is well-documented and if Ketamir-2 can replicate or improve these effects with fewer side effects, it could significantly impact treatment protocols.
However, the transition from preclinical to clinical stages often faces challenges, including variability in human responses compared to animal models and the stringent safety profiles required by regulatory bodies. The dual focus on both PTSD and pain management broadens the therapeutic scope, potentially increasing the market size and value for MIRA.
From a financial perspective, Mira Pharmaceuticals' progress towards an IND submission for Ketamir-2 marks a pivotal development. The IND submission, if successful, would allow the transition from preclinical studies to human clinical trials, a critical milestone that often results in increased investor confidence and potential stock value appreciation. The optimization of the manufacturing process to reduce costs is another positive signal, indicating the company's proactive approach in preparing for large-scale production.
The market for PTSD treatments is projected to reach
However, the preclinical stage still carries inherent risks, including potential setbacks in clinical trials and regulatory hurdles. Investors should consider these risks alongside the potential rewards. The company's strategic collaborations and manufacturing advancements are positive indicators but do not eliminate the inherent uncertainties of drug development.
Investigative studies are underway testing Ketamir-2 as the potential first at home ketamine analog treatment for PTSD, depression, and neuropathic pain, including cancer pain
MIRA continues to advance studies of Ketamir-2 in animal studies while improving manufacturing optimization as the company prepares for human testing in 2025.
MIRA anticipates that positive results from these preclinical studies will enable the submission of an Investigational New Drug Application (IND) to the
Development Update:
Initiation of Preclinical Trials with Pharmaseed for PTSD
MIRA has initiated a preclinical trial in collaboration with Pharmaseed Ltd ("Pharmaseed") to evaluate the efficacy of Ketamir-2 as compared with Ketamine in a rat model of severe PTSD. This study, designed to assess the alleviation of symptoms of chronic stress and behavioral consequences of dysfunctional processing of fear and fear memory, leverages established models demonstrating the effectiveness of ketamine in treating PTSD symptoms. While ketamine has demonstrated rapid and sustained reduction in PTSD symptoms in several clinical studies, it has to be given through intravenous, intramuscular or intranasal administration. The current study is designed to provide robust data on the potential for the orally administered Ketamir-2 through behavioral tests, biomarker analysis, and immunohistochemistry to support future clinical applications. Ongoing studies at Pharmaseed are already exploring the potential of Ketamir-2 in treating depression and several forms of pain, including neuropathic pain.
Head-to-Head Preclinical Study to be Conducted by Biotrial, Inc. for Locomotor Activity Evaluation of Ketamir-2 Compared to Ketamine
In parallel, MIRA has initiated a study with Biotrial, Inc. (Biotrial) to evaluate the acute effects of Ketamir-2 on spontaneous locomotor activity in mice. This study will assess Ketamir-2's impact compared to ketamine and a control vehicle, providing crucial data on the pharmacodynamics of Ketamir-2. Ketamine is known to produce a biphasic effect on locomotion (meaning high and low doses of ketamine have very different effects). The initial hypolocomotion (reduced movement) phase observed in rodents after ketamine administration is consistent with the sedative and dissociative effects reported with ketamine in humans, which can lead to impaired coordination and motor function. The subsequent hyperlocomotion (increased movement) phase in rodents mirrors the agitation, confusion and psychotic effects seen in humans, particularly at higher doses of ketamine. Since Ketamir-2 has a different chemical profile that ketamine, MIRA anticipates that these head-to-head studies can be predictive of Ketamir-2's side-effect profile in humans.
Initiation of 7-Day Animal Studies with Frontage
MIRA is also advancing towards regulatory IND-enabling study and has also initiated 7-day rat and dog toxicology studies with Frontage Laboratories. These studies are critical steps towards ensuring the safety and efficacy of Ketamir-2 in preparation for human clinical trials.
Advancements in Ketamir-2 Manufacturing
In recent weeks, MIRA has also made significant advancements in the manufacturing process of Ketamir-2, markedly simplifying and optimizing the synthetic process while reducing production costs and overall cost of goods. These improvements are critical as MIRA scales up production under Good Manufacturing Practices (GMP) to enable the required regulatory toxicology studies and to prepare for an IND for Ketamir-2 submission later this year.
Potential of Ketamir for PTSD Treatment
According to the National Institutes of Health, PTSD affects approximately 8 million adults annually in
Exploring Collaborations for Cancer Pain Studies
In addition to its current initiatives, MIRA is also in discussions with several research centers to potentially collaborate on studying Ketamir-2's efficacy in treating cancer pain. These collaborations could expedite the IND submission for Ketamir-2 and the commencement of human clinical trials, while increasing the potential therapeutic applications of Ketamir-2.
Management Comments
Erez Aminov, Chairman and CEO of Mira Pharmaceuticals, commented, "The initiation of these preclinical trials represents a significant milestone in our mission to develop next-generation treatments for severe mental health disorders as well as neuropathic pain. Our collaboration with Pharmaseed and Biotrial underscores our commitment to advancing Ketamir-2 towards clinical development in humans and addressing the urgent needs of those suffering from PTSD and other debilitating conditions. The financial impact of medication-treated major depressive disorder in the
Dr. Itzchak Angel, Chief Scientific Advisor of Mira Pharmaceuticals, added, "The data generated from these studies will be invaluable in demonstrating Ketamir-2's potential benefits. What sets Ketamir-2 apart from ketamine is its high oral bioavailability and lack of mu opioid interaction. As a result, Ketamir-2 potentially offers a safer and more effective option for oral administration, providing rapid relief for depression in a home setting. We are excited about the progress we have made in simplifying the drug's manufacturing process and are hopeful that Ketamir-2 can offer new hope for patients with PTSD and other mental health and pain conditions."
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
In addition, MIRA's novel oral pharmaceutical marijuana, MIRA-55, is currently under investigation for treating adult patients suffering from 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.
Additional information about the Company is available at: www.mirapharmaceuticals.com.
Ketamir-2 and MIRA-55 are in early stage pre-clinical development. There is no assurance that the products will proceed through development or will receive FDA approval for marketing.
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1 The Journal of Clinical Psychiatry, PMID: 33989464 |
2 Allied Market Research: Post-Traumatic Stress Disorder Treatment Market Research, 2031 |
Cautionary Note Regarding Forward-Looking Statements
This press release and 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 in this press release that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding Ketamir-2's potential in treating certain mental health conditions or neuropathic pain and statements regarding the timing for the Company's 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 (including the anticipated benefits of the Company's pre-clinical testing and pre-clinical data discussed herein) 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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SOURCE MIRA Pharmaceuticals, Inc.
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