Mira Pharmaceuticals provides update on preparing IND submission

MIRA Pharmaceuticals provides a comprehensive update on its recent achievements and scientific advancements as it nears a crucial milestone: the submission of its Investigational New Drug application by the end of the year. Recent Company Highlights: Leadership Enhancement with Dr. Itzchak Angel: MIRA has strengthened its leadership by appointing Dr. Itzchak Angel as Chief Scientific Advisor. MIRA has made significant strides with its novel oral ketamine analog, Ketamir-2. The Company has established a robust manufacturing process for the compound, which allows large-scale, high-quality synthesis with low cost of goods. Recent preclinical studies have demonstrated that Ketamir-2 offers a superior safety profile compared to traditional ketamine, notably avoiding hyper-locomotor activity-a behavior linked to psychotic symptoms-thereby positioning it as a potentially safer option for mental health treatments. The Company has further explored the pharmacological profile of the compound in animal models of anxiety and depression. Significant dose-depended effects were observed upon oral administration of the compound to mice in models such as Elevated Plus Maze, Open Filed and Forced Swim Tests. The Company’s key discoveries include Ketamir-2’s non-substrate status for P-glycoprotein, which allows for better oral absorption and improved passage through the blood-brain barrier, and potentially higher efficacy at lower doses. Further analysis has shown that Ketamir-2 selectively inhibits the NMDA receptor at the PCP-binding site with 30-50 times lower affinity than traditional ketamine, reducing the risk of side effects such as dissociation and hallucinations. In addition to these findings, MIRA recently unveiled new data on Ketamir-2’s principal metabolite, Nor-Ketamir, which demonstrates a longer-acting, brain-penetrating profile. Nor-Ketamir has shown nearly 100% oral bioavailability, compared to intravenous Ketamir-2 and sustained plasma residence, leading to extended therapeutic efficacy. The development of a new salt form, Ketamir-2 Pamoate, with an improved formulation have further enhanced the pharmacokinetics of Ketamir-2, ensuring overall higher plasma and brain levels with a longer half-life. These advancements suggest that Ketamir-2 and Nor-Ketamir could offer effective, at-home treatment options for neurological and neuropsychiatric disorders, setting a new standard for patient care. The safety profile of Ketamir-2 has been further validated in toxicology studies in mice, rats and dogs, where minimal toxicity was observed at very high doses in animal models. This robust safety data, combined with its strong antidepressant and anxiolytic activities at lower doses, positions Ketamir-2 as a potentially transformative treatment for conditions such as depression, treatment-resistant depression, and post-traumatic stress disorder. MIRA-55, the Company’s novel oral pharmaceutical marijuana analog, continues to show promising results in preclinical studies, demonstrating significant advantages over THC. Recent tests confirmed that MIRA-55 exhibits higher efficacy at both the CB1 and CB2 cannabinoid receptors compared to THC, with a more pronounced and sustained increase in agonist activity. This indicates MIRA-55’s potential for greater effectiveness in treating anxiety, cognitive decline, and other neurological conditions. Moreover, MIRA-55 maintains a consistent anxiolytic effect across a broader range of doses without losing effectiveness, unlike THC. The DEA’s determination that MIRA-55 is not a controlled substance removes significant regulatory barriers, enabling the company to advance its development as a safer, more effective treatment for various neuropsychiatric disorders. MIRA Pharmaceuticals is finalizing its IND application for Ketamir-2, focusing on scaling up Good Manufacturing Practice processes and completing Chemistry, Manufacturing, and Controls documentation. Additionally, MIRA has initiated the final stage in its regulatory safety studies, a critical step towards ensuring the safety and efficacy of Ketamir-2 in preparation for clinical trials. The company is also exploring accelerated clinical trial pathways, such as orphan indications or cancer-related indications, which could provide faster access to clinical trials and bring Ketamir-2 to patients sooner. MIRA continues to work with research organizations like Pharmaseed and Biotrial to further validate Ketamir-2’s efficacy and safety, with additional studies targeting conditions such as PTSD and neuropathic pain.