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 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.
FAQ
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