MIRA advances Ketamir-2 in the clinic for neuropathic pain while broadening development into neuropsychiatric disorders such as PTSD

MIAMI, FLORIDA / ACCESS Newswire / September 16, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced positive results demonstrating that its oral drug candidate Ketamir-2 restored normalized behavior in stressed animals within a validated model of post-traumatic stress disorder (PTSD). Ketamir-2 is currently being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, where it has shown a favorable safety profile to date.

"Restoring behavior to normal in a stressed PTSD model represents an important step forward," said Erez Aminov, CEO of MIRA Pharmaceuticals. "These findings support our decision to broaden the scientific evaluation of Ketamir-2 beyond neuropathic pain into neuropsychiatric disorders such as PTSD. Looking ahead, we plan to explore opportunities for potential collaborations, including with military and government institutions, given the significant unmet need for effective PTSD treatments."

This proof-of-concept validation study was conducted in a small group of rats using the Single Prolonged Stress (SPS) model, a widely accepted paradigm for inducing inescapable stress that mimics PTSD symptoms in animals. Animals were exposed twice to a predator stressor (bobcat urine), which is known to induce "depression-like" symptoms and changes in active/passive coping. Increased immobility after stress exposure reflects enhanced affective impairment or reduced stress resilience. Following the development of these symptoms, animals were dosed orally with Ketamir-2 once daily for five consecutive days.

Behavioral assessments included anxiety- and coping/resilience-related behavior in the forced swim test (FST), which measures immobility versus active coping strategies.

Outcome: stressed animals displayed hallmark PTSD-like behaviors, including increased despair, immobility, and avoidance of coping. Treatment with Ketamir-2 reversed these types of behaviors, restoring them toward the level observed in non-stressed animals. This initial validation supports the study design, and a larger follow-on PTSD study is ongoing.

"These preliminary results reinforce the therapeutic potential of Ketamir-2 in PTSD," said Dr. Itzchak Angel, Chief Scientific Advisor of MIRA. "We observed consistent reversal of stress-induced behavioral changes, supporting continued investigation of Ketamir-2 across neuropsychiatric disorders."

PTSD: A Major Unmet Need

• PTSD affects an estimated 13 million adults in the United States each year, with approximately 6% of U.S. adults experiencing PTSD at some point in their lives.

• The economic and social burden of PTSD is estimated at $232 billion annually in the U.S., driven by lost productivity, medical care, and disability.

• The treatment landscape is limited:

  • Only two FDA-approved medications exist for PTSD (sertraline and paroxetine, both SSRIs), which provide limited relief and are often poorly tolerated (FDA PTSD treatments).

  • Psychotherapies such as CBT and EMDR can be effective, but access, adherence, and dropout rates remain significant challenges.

• The U.S. Department of Defense and Veterans Affairs continue to invest heavily in novel PTSD research, underscoring the urgent need for safer and more effective solutions for service members and veterans.

About Ketamir-2

Ketamir-2 is a proprietary, orally bioavailable new molecular entity that selectively targets the NMDA receptor (PCP site) with low affinity and demonstrates no significant off-target activity across a broad receptor panel. Ketamir-2 was designed to capture the therapeutic efficacy of ketamine while minimizing the unwanted dissociative and other central nervous system side effects that limit ketamine's clinical use. 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. Previous animal studies have also shown Ketamir-2's superior efficacy versus ketamine, pregabalin, and gabapentin in neuropathic pain models.

Cautionary Note Regarding Forward-Looking Statements

This press release and the statements of MIRA's management related thereto contain "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. Any forward-looking statements in this press release are based on MIRA'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 MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at www.sec.gov and on MIRA's website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

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

SOURCE: MIRA Pharmaceuticals