MIRA Pharmaceuticals Showcases Significant Progress and Announces Final Phase of Regulatory Work as It Prepares for IND Submission by Year-End

MIAMI, FL / ACCESSWIRE / August 19, 2024 / MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) “MIRA” or the “Company”), a leading pre-clinical-stage pharmaceutical company, is pleased to provide a comprehensive update on its recent achievements and scientific advancements as it nears a crucial milestone: the submission of its Investigational New Drug (IND) application by the end of the year. This update highlights the company’s strategic progress, significant scientific breakthroughs, and the expertise driving its innovative drug candidates toward clinical trials.

Recent Company Highlights

• Leadership Enhancement with Dr. Itzchak Angel
  MIRA has strengthened its leadership by appointing Dr. Itzchak Angel as Chief Scientific Advisor. With over 40 years of experience, including a distinguished career at Synthelabo (now Sanofi-Aventis), Dr. Angel was instrumental in the development and regulatory approval of several key drugs, such as Ambien, Xatral and Mizolen. His expertise in advancing drug candidates from early research through clinical trials is now guiding MIRA’s pipeline​.

• Scientific Progress with Ketamir-2
  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 (P-gp), 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 (TRD), and post-traumatic stress disorder (PTSD).

• Regulatory Milestone for MIRA-55
  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​​.

Ongoing Activities and Future Plans

MIRA Pharmaceuticals is finalizing its IND application for Ketamir-2, focusing on scaling up Good Manufacturing Practice (GMP) processes and completing Chemistry, Manufacturing, and Controls (CMC) 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.

Quote from Chairman and CEO

“Our mission at MIRA Pharmaceuticals is to bring easy access, affordable, and safer drugs to those suffering from neurological and neuropsychiatric disorders. The latest advancements with Ketamir-2 and MIRA-55 reinforce our commitment to transforming patient care by offering innovative treatments that can be effectively administered at home. We remain dedicated to pushing the boundaries of what’s possible in drug development to ensure that patients have access to the best possible therapies,” said Erez Aminov, Chairman and CEO of MIRA Pharmaceuticals.

About MIRA Pharmaceuticals

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. MIRA holds the exclusive U.S., Canadian and Mexican rights for Ketamir-2, a novel, patent pending oral ketamine analog under investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression, major depressive disorder with suicidal ideation and post-traumatic stress disorder. The U.S. Drug Enforcement Administration’s scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations.

In addition, MIRA’s novel oral pharmaceutical marijuana analog, MIRA-55, is currently under investigation for treating adult patients suffering from neuropathic pain as well as anxiety and cognitive decline, often associated with early-stage dementia. MIRA-55, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders. The U.S. Drug Enforcement Administration’s scientific review of MIRA-55 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations. Additional information about MIRA Pharmaceuticals is available at: www.mirapharmaceuticals.com

Ketamir-2 and MIRA-55 are in early-stage preclinical development. There is no assurance that the products will proceed through development or will receive FDA approval for marketing.

Cautionary Note Regarding Forward-Looking Statements

This press release and the statements of MIRA Pharmaceuticals’ (or the “Company”) management related thereto contains “forward-looking statements,” which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the study results described herein as well as the timing for the Company’s other preclinical studies and the filing of an IND for Ketamir-2. Any forward-looking statements in this press release are based on the Company’s current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company’s control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company’s programs and operations are described in additional detail in Annual Report on Form 10-K for the year ended December 31, 2023 and other SEC filings, which are on file with the SEC at www.sec.gov and the Company’s website at https://www.mirapharmaceuticals.com/investors/sec-filings. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact Information

Helga Moya
info@mirapharma.com
(786) 432-9792

SOURCE: Mira Pharmaceuticals Inc.

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