MIRA Pharmaceuticals Advances Potential First At-Home Ketamine Treatment for PTSD

MIRA Pharmaceuticals (Nasdaq: MIRA) is advancing closer to clinical development of what could potentially be the first at-home ketamine-based treatment for post-traumatic stress disorder (PTSD). MIRA is evaluating Ketamir-2, its differentiated oral ketamine analog, for the treatment of severe PTSD, along with other mental health disorders and neuropathic pain indications. The company’s share price soared nearly 40% in trading on Monday morning following the news, and the company topped the PRISM Emerging Psychedelics Index.

MIRA said in a statement that it is completing animal studies and preparing for human testing, which it expects to commence in 2025. The company anticipates that positive results from its preclinical studies will enable the submission of an Investigational New Drug Application (IND) to the FDA by the end of 2024.

PTSD affects approximately eight million adults annually in the United States, with current treatments often providing limited relief and significant side effects

Erez Aminov, Chairman and CEO of Mira Pharmaceuticals, commented, “The initiation of these preclinical trials represents a significant milestone in our mission to develop next-generation treatments for severe mental health disorders as well as neuropathic pain.  Our collaboration with Pharmaseed and Biotrial underscores our commitment to advancing Ketamir-2 towards clinical development in humans and addressing the urgent needs of those suffering from PTSD and other debilitating conditions.” 

The financial impact of medication-treated major depressive disorder in the US is $92.7 billion annually, with $43.8 billion, and the US market for post-traumatic stress disorder treatments is projected to reach $26 billion by 2031.

About MIRA Pharmaceuticals, Inc.

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, MIRA-55, is currently under investigation for treating adult patients suffering from 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.

Additional information about the Company is available at: www.mirapharmaceuticals.com.

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MIRA Pharmaceuticals Advances Potential First At-Home Ketamine Treatment for PTSD

Catie Corcoran

Biotech Editor