Mira Pharma - MIRA STOCK NEWS

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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.