The company is evaluating the oral ketamine analog as a fast-acting antidepressant.
Ketamier-2, MIRA Pharmaceuticals’ oral ketamine analog, demonstrated excellent stability in the bloodstream and showed the potential to be metabolized effectively and safely in pre-clinical trials, the company said.
The company is evaluating the oral ketamine analog as a potential therapeutic for individuals battling treatment-resistant depression, major depressive disorder with suicidal ideation and post-traumatic stress disorder.
MIRA is conducting pre-clinical studies of Ketamir-2 in collaboration with Frontage Laboratories.
The latest in vitro research focused on Ketamir-2’s stability in the bloodstream, its metabolism (processing by the body) and how it binds to proteins in the blood, according to the company. “These factors play a crucial role in determining a drug’s adequacy and likelihood for acceptable safety, its pharmacological profile and potential modes of administration to patients,” MIRA said in a news release.
MIRA provided the following summary of the pre-clinical studies:
- Blood stability and distribution – Ketamir-2 demonstrated excellent stability in blood from various species, including humans. This means that once in the bloodstream, Ketamir-2 remains unchanged for a sufficient duration, allowing it to potentially exert its therapeutic effects effectively.
- Metabolic profile –The studies indicate the potential for Ketamir-2 to be metabolized effectively and safely. The clear identification of specific liver enzymes hints at the potential for Ketamir-2 having fewer interactions with other medications, addressing a common concern among doctors and patients.
- Protein binding –Ketamir-2 appears to bind optimally to blood proteins, which suggests the potential for effective delivery throughout the body. This property is crucial for distributing the drug to brain areas where it can exert its effects.
- Safety profiles –Initial toxicology assessments provide a favorable safety profile crucial for advancement through regulatory review and clinical trials.
MIRA said the company is hopeful that the results of the most recent studies will enable MIRA to file an investigational new-drug application (IND) with the U.S. Food and Drug Administration by the end of the year. If accepted, the IND would allow for human testing of Ketamir-2.
“The data we have obtained from these studies is invaluable,” MIRA Chief Scientific Advisor Itzchak Angel said. “They not only enhance our understanding of Ketamir-2 but also underscore its potential benefits for patients with TRD and PTSD and pave the way for what we believe will be straightforward IND-enabling development.”