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About Mira Pharmaceuticals, Inc.
Mira Pharmaceuticals, Inc. (NASDAQ: MIRA) is a preclinical-stage pharmaceutical development company specializing in innovative treatments for neurologic and neuropsychiatric disorders. With a focus on addressing significant unmet medical needs, Mira Pharma is advancing two promising drug candidates: Ketamir-2, a novel oral ketamine analog, and MIRA-55, an oral pharmaceutical marijuana analog. These programs target conditions such as neuropathic pain, anxiety, cognitive decline, treatment-resistant depression (TRD), and post-traumatic stress disorder (PTSD).
Core Innovations
Ketamir-2: Ketamir-2 is engineered to overcome the limitations of traditional ketamine therapies. Unlike ketamine, which suffers from poor oral bioavailability and significant psychotropic side effects, Ketamir-2 selectively targets the NMDA receptor with reduced risk of dependency, sedation, or cognitive impairment. Preclinical studies have demonstrated its ability to achieve 100% pain reversal in neuropathic pain models, outperforming FDA-approved treatments like gabapentin and pregabalin. Ketamir-2 also shows potential for treating mental health conditions such as TRD and PTSD, offering a safer, non-addictive alternative to existing therapies.
MIRA-55: MIRA-55 is a novel oral pharmaceutical marijuana analog under investigation for treating anxiety and cognitive decline, particularly in early-stage dementia. By balancing activity on CB1 and CB2 cannabinoid receptors, MIRA-55 offers a more consistent therapeutic effect compared to THC, with fewer side effects. Its non-controlled substance classification simplifies regulatory pathways and manufacturing processes.
Strategic Positioning
Mira Pharmaceuticals operates in the rapidly growing neuroscience market, addressing critical gaps in pain management and mental health treatment. Its drug candidates are designed to provide safer, more effective alternatives to opioids, traditional ketamines, and other existing therapies. The company’s strong preclinical safety data and innovative study designs position it for success in clinical trials, with plans to initiate Phase I studies for Ketamir-2 in Q1 2025.
Competitive Advantages
- Non-Addictive Solutions: Both Ketamir-2 and MIRA-55 are designed to minimize risks of dependency, addressing the growing demand for safer pain and mental health treatments.
- Enhanced Bioavailability: Ketamir-2’s superior oral absorption and blood-brain barrier penetration offer significant advantages over traditional ketamine therapies.
- Regulatory Simplicity: The non-controlled substance classification of both drug candidates reduces regulatory hurdles, streamlining the path to commercialization.
- Broad Therapeutic Potential: While initially targeting neuropathic pain and anxiety, Mira’s drug candidates hold promise for expanding into other indications, including TRD, PTSD, and cancer-induced neuropathy.
Market Context
The North American neuropathic pain market alone is projected to grow to $5.2 billion by 2030, driven by rising prevalence rates and unmet needs. Current treatments like gabapentin and pregabalin are limited by side effects and efficacy challenges, creating a significant opportunity for novel therapies like Ketamir-2. Additionally, the mental health crisis underscores the need for innovative solutions to conditions like PTSD and TRD, further expanding Mira’s addressable market.
Commitment to Excellence
Mira Pharmaceuticals adheres to rigorous scientific and regulatory standards, with a strong focus on safety, efficacy, and patient outcomes. Its robust preclinical data, coupled with strategic partnerships and advanced study designs, underscores its commitment to delivering transformative therapies that improve quality of life for patients worldwide.
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.
Mira Pharmaceuticals announced that its novel drug MIRA-55 has been ruled by the DEA as not being a controlled substance. This decision eliminates regulatory barriers for manufacturing, research, and commercialization. MIRA-55, aimed at treating neuropathic pain, anxiety, and cognitive decline, shows promise in enhancing memory and cognitive performance without the adverse effects associated with THC in marijuana. The drug also demonstrates stable anti-anxiety effects and reduced intoxicating effects, providing a significant advantage over traditional cannabis. With access to large neurological and cannabis markets, MIRA-55 represents a promising value for the company.
MIRA Pharmaceuticals (NASDAQ: MIRA) is in advanced talks with Memorial Sloan Kettering Cancer Center (MSK) to evaluate MIRA's novel oral ketamine analog, Ketamir-2, for cancer-related pain and depression. This collaboration could validate Ketamir-2's potential and expand its application beyond depression and PTSD. MSK currently treats refractory cancer pain with intravenous ketamine, but Ketamir-2 may offer a more convenient oral alternative with higher bioavailability and a better safety profile. The study will compare Ketamir-2's efficacy to traditional ketamine in rodent models. MIRA also collaborates with Pharmaseed to explore Ketamir-2's effects on neuropathic pain. Successful preclinical results could accelerate FDA approval and create non-dilutive funding opportunities. Cancer pain affects 44% of patients, with 31% experiencing moderate to severe pain, and 25% suffering from depression.
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.
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