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
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).
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.