Company: MIRA
Filing Date: 2025-07-29
Form Type: PRER14A
Source: 0001641172-25-021434
Chunk: 19

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-07-29
Form: PRER14A
Chunk 19
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 neuralgia), autoimmune diseases, chemotherapy-induced neuropathy, traumatic nerve injury, stroke, or spinal cord injury.

Existing treatment options include antidepressants (tricyclic antidepressants and serotonin-norepinephrine reuptake inhibitors), anticonvulsants (gabapentin and pregabalin), topical agents (lidocaine patches and capsaicin), and opioids. However, these therapies often provide incomplete relief, have significant side effects, and, in the case of opioids, carry a high risk of addiction. Ketamine has demonstrated efficacy for neuropathic pain, but its poor oral bioavailability and high risk of side effects have limited its widespread use. Ketamir-2 aims to address these challenges, offering a treatment with fewer side effects, lower abuse potential, and more convenient oral dosing.

MIRA-55 is a preclinical-stage investigational drug designed to support cognitive function and enhance memory. It is currently being evaluated in preclinical studies for its potential benefits in inflammatory pain. If approved, MIRA-55 could provide a breakthrough treatment for patients experiencing cognitive decline and inflammatory pain, including those with early neurodegenerative conditions.

Regulatory and DEA Classification

The U.S. Drug Enforcement Administration (DEA) has completed its scientific review of both Ketamir-2 and MIRA-55, determining that neither compound will be classified as a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations. This regulatory distinction significantly enhances their commercial and clinical viability, removing potential barriers associated with controlled substances and positioning both compounds for streamlined clinical development and commercialization.

MIRA remains committed to advancing Ketamir-2 and MIRA-55 through clinical development with a focus on addressing major unmet medical needs and improving patient outcomes.

Preclinical Studies and Pharmacology of Ketamir-2

MIRA has conducted extensive preclinical studies to characterize the pharmacological profile, safety, and therapeutic potential of Ketamir-2, an investigational compound targeting neuropathic pain, treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDD-SI), and post-traumatic stress disorder (PTSD). These studies, performed in accordance with ICH and FDA regulatory guidelines, include in vitro and in vivo assessments to evaluate receptor binding, efficacy, selectivity, pharmacokinetics, metabolism, general pharmacology and toxicology.

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Mechanism of Action and Receptor Selectivity Ketamir-2 has been identified as a low-affinity NMDA