Welcome to our dedicated page for Mira Pharma news (Ticker: MIRA), a resource for investors and traders seeking the latest updates and insights on Mira Pharma stock.
Overview
Mira Pharmaceuticals Inc (NASDAQ:MIRA) is a preclinical-stage pharmaceutical development company dedicated to advancing innovative therapies for a wide spectrum of neurological and neuropsychiatric disorders. With a targeted focus on neuroscience, the company is developing two major drug candidates: a novel oral ketamine analog, Ketamir-2, and an oral pharmaceutical marijuana analog, MIRA-55.
Innovative Drug Candidates
Ketamir-2: This oral ketamine analog is engineered to combat neuropathic pain, treatment-resistant depression, and other neuropsychiatric conditions. Its unique mechanism of action focuses on selective inhibition of the NMDA receptor at the PCP-binding site with a reduced affinity compared to traditional ketamine. This selective binding potentially minimizes psychotropic side effects such as dissociation and hallucinations while ensuring improved oral bioavailability and enhanced brain penetration through non-interaction with P-glycoprotein (P-gp).
MIRA-55: The company is also developing an innovative oral formulation of a pharmaceutical marijuana analog aimed at treating neuropathic pain, anxiety, and cognitive decline often seen in early-stage dementia. Its development is supported by rigorous preclinical studies that highlight a favorable safety profile and a potentially improved efficacy compared to traditional compounds in this space.
Scientific and Clinical Focus
Leveraging strong preclinical data, Mira Pharma emphasizes the design and optimization of drug formulations that demonstrate both safety and efficacy. Their research indicates that Ketamir-2, with its exclusive mechanism and elevated bioavailability, could offer a more consistent therapeutic effect at lower doses. The company is also focused on developing improved formulations, such as the Ketamir-2 Pamoate salt, intended to enhance pharmacokinetic profiles and patient compliance.
Regulatory and Developmental Milestones
Mira Pharma’s robust preclinical studies have paved the way toward submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The firm’s strategic roadmap includes planned Phase I clinical trials to evaluate safety, pharmacokinetics, and tolerability in healthy volunteers, followed by proof-of-concept studies in patients suffering from neuropathic pain and other targeted conditions. This structured clinical development approach underlines their commitment to transforming novel preclinical insights into practical, safe treatment options.
Market Position and Competitive Landscape
Operating within the competitive realm of pharmaceutical innovation, Mira Pharma differentiates itself by focusing on non-opioid alternatives and compounds with a cleaner pharmacological profile. Their pioneering approach in developing selective NMDA receptor modulators and leveraging enhanced oral drug delivery mechanisms set them apart from traditional therapies. Although still in the preclinical stage, their work is aimed at addressing significant unmet medical needs in neurological and neuropsychiatric therapy markets.
Research, Expertise, and Future Considerations
Mira Pharma is anchored by a team of experienced researchers and industry veterans who blend deep scientific expertise with strategic regulatory planning. Their rigorous preclinical research underscores a commitment to scientific excellence and the development of safer, more effective treatment modalities. The company’s unbiased and evidence-based approach ensures that each clinical development milestone is built on robust data, reflecting a high degree of authoritativeness and trustworthiness in its scientific communications.
MIRA Pharmaceuticals (NASDAQ:MIRA) has announced significant progress in the clinical development of its novel oral ketamine analog, Ketamir-2. The company has initiated drug product development in collaboration with Formulex, focusing on spray-dry based granulation in capsules. MIRA is on track for its Investigational New Drug (IND) filing with the FDA in December 2024. The company aims to demonstrate clinical efficacy for neuropathic pain as early as 2025 through innovative Phase I/II study designs. MIRA has finalized its Phase I clinical trial design, set to begin in early Q1 2025, assessing safety, tolerability, and pharmacokinetics in humans. The company is also exploring additional indications in mental health, including Major Depressive Disorder with Suicidal Ideation, Treatment-Resistant Depression, and Post-Traumatic Stress Disorder.
MIRA Pharmaceuticals (NASDAQ:MIRA) has chosen neuropathic pain as the primary indication for its novel oral ketamine analog, Ketamir-2. The company has submitted a pre-IND meeting request to the FDA, expected in November 2024. MIRA aims to submit its IND by year-end, with human trials anticipated in Q1 2025.
Ketamir-2 is designed to offer enhanced therapeutic efficacy, improved oral bioavailability, and a superior safety profile compared to existing treatments. It's a non-opioid, non-controlled substance, potentially offering safer and more accessible pain relief. The North American neuropathic pain market is projected to reach $5.2 billion by 2030, driven by an aging population and increasing prevalence of conditions like diabetes.
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.
MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) has made significant progress in its drug development programs, particularly with its novel oral ketamine analog, Ketamir-2. The company has enhanced its leadership by appointing Dr. Itzchak Angel as Chief Scientific Advisor. Recent preclinical studies have shown that Ketamir-2 offers a superior safety profile compared to traditional ketamine, with potential applications in treating depression, anxiety, and PTSD.
MIRA has also advanced its MIRA-55 program, a novel oral pharmaceutical marijuana analog, which has demonstrated higher efficacy at cannabinoid receptors compared to THC. The company is finalizing its Investigational New Drug (IND) application for Ketamir-2, with plans to submit by year-end. This progress positions MIRA to potentially transform patient care in neurological and neuropsychiatric disorders with innovative, at-home treatment options.
MIRA Pharmaceuticals (NASDAQ:MIRA) has unveiled new preclinical data on Ketamir-2's principal metabolite, Nor-Ketamir-2. The findings show that Nor-Ketamir-2 selectively interacts with the NMDA PCP site, demonstrating high selectivity and lack of activity on other sites. A new salt, Ketamir-2 Pamoate, and associated formulation were developed to enhance pharmacokinetics and improve brain penetration.
Key advantages over traditional ketamine include:
- Nearly 100% oral bioavailability of Nor-Ketamir-2
- Sustained plasma residence and brain penetration
- Extended therapeutic efficacy
- Improved safety profile
MIRA is conducting studies for potential indications such as cancer neuropathic pain, chemo-induced depression, and PTSD. The company plans to submit an Investigational New Drug (IND) application by year-end.
MIRA Pharmaceuticals (NASDAQ:MIRA) has announced positive preclinical data for its novel oral ketamine analog, Ketamir-2, bringing it closer to a potential IND submission this year. The latest findings reveal that Ketamir-2 is a selective inhibitor of the NMDA receptor, specifically interacting at the PCP-binding site with 30-50-fold lower affinity compared to ketamine. This selectivity may lead to reduced side effects and an improved safety profile.
Toxicology studies in rats and dogs have shown no toxicity at high doses, indicating an excellent safety margin. Ketamir-2 also demonstrates pronounced antidepressant and anxiolytic activities at lower doses. The compound's unique selectivity and robust safety data enhance its potential as a transformative treatment for neurological and neuropsychiatric disorders, including depression, treatment-resistant depression, and PTSD.
MIRA Pharmaceuticals (NASDAQ:MIRA) has announced promising preclinical results for Ketamir-2, its novel oral ketamine analog. The drug shows potential advantages over traditional ketamine for treating neurological and neuropsychiatric disorders. Key findings include:
1. Better brain penetration due to non-interaction with P-glycoprotein
2. Higher oral bioavailability (80% vs. <30% for ketamine)
3. Improved safety profile with no hyper-locomotor activity or mu-opioid receptor interaction
4. Significant anti-depressive and anxiolytic effects in mouse models
MIRA aims to submit an IND application to the FDA by year-end for human testing. The company is also exploring orphan drug indications for conditions like multiple sclerosis-induced depression and Huntington's disease-induced depression.
MIRA Pharmaceuticals (Nasdaq: MIRA) has announced promising results from preclinical studies of its novel oral pharmaceutical marijuana analog, MIRA-55. The compound, being studied as a potential treatment for anxiety and cognitive decline, showed significant advantages over THC in multiple tests.
Key findings include:
- Higher efficacy at CB1 and CB2 cannabinoid receptors compared to THC
- More pronounced and sustained agonist activity as concentration increases
- Consistent, dose-dependent reduction in anxiety-like behaviors
- Maintained efficacy across a broader range of doses
- Promising toxicological profile, indicating potential safer profile for human use
These results confirm MIRA's earlier beliefs about MIRA-55's pharmacological profile and its potential for enhanced potency and efficacy in treating neurological and neuropsychiatric disorders.
MIRA Pharmaceuticals (NASDAQ: MIRA) has announced promising preclinical results for its oral ketamine analog, Ketamir-2, showing it does not induce hyper-locomotor activity, a psychotic symptom common with traditional ketamine use.
This indicates Ketamir-2 could offer safer mental health treatments. Conducted with Biotrial, the study evaluated Ketamir-2's effects on spontaneous locomotor activity in mice. Unlike traditional ketamine, Ketamir-2 did not trigger hyperlocomotion, suggesting reduced risks of psychotic behaviors and misuse.
MIRA plans to submit an IND application to the FDA by year-end. This development positions Ketamir-2 for broader psychiatric and neurologic applications, potentially reducing healthcare costs for conditions like treatment-resistant depression, which currently costs the U.S. $43.8 billion annually.
Further studies on Ketamir-2's safety and efficacy are ongoing, with potential applications for cancer pain and PTSD.
MIRA Pharmaceuticals announced positive preclinical results for Ketamir-2, an oral ketamine analog, suggesting it as a potential superior alternative to traditional ketamine for treating depression and treatment-resistant depression (TRD). The study conducted by Pharmaseed revealed that Ketamir-2 showed higher efficacy and safety compared to oral ketamine in male mice, with significant improvements in locomotor activity, reduced anxiety, and antidepressant effects. Unlike ketamine, Ketamir-2 can be administered orally, promising better patient compliance and is not a controlled substance under DEA rules. MIRA plans to submit an Investigational New Drug Application (IND) to the FDA later this year to initiate human trials.
FAQ
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