The Potential Of Ketamir-2: A Safer Treatment For Mental Health Disorders And Neuropathic Pain, IND Filing Expected By Year-End

Treating mental health is constantly evolving, bringing new therapies and hope to people battling depression, treatment-resistant depression (TRD), post-traumatic stress disorder (PTSD) and other neuropsychiatric conditions. Not all therapies work for everyone, but sometimes an exciting treatment emerges. Ketamine, originally developed as an anesthetic, falls into that category. In recent years, it has been repurposed as a rapid-acting antidepressant, particularly for patients who have not responded to conventional treatments. 

While often effective, ketamine's widespread use has been limited by its side effects and low oral bioavailability. Traditional ketamine requires intravenous or intranasal administration, which can be inconvenient and impractical for at-home treatment. Additionally, ketamine's interaction with multiple receptor sites in the brain can lead to unwanted side effects such as dissociation, hallucinations and, in some cases, psychotic symptoms. 

Tweaking Ketamine

But that doesn't mean ketamine has to be written off as a new treatment for mental health. It just needs to be tweaked. That's where MIRA Pharmaceuticals MIRA and Ketamir-2 come in. A pre-clinical-stage pharmaceutical company, MIRA is refining this treatment with its oral ketamine analog, Ketamir-2. 

MIRA Pharmaceuticals says Ketamir-2 is a groundbreaking compound that has the potential to revolutionize the way mental health disorders and neuropathic pain are treated, offering a safer and more effective alternative to traditional therapies. The company is on track to file an Investigational New Drug (IND) application by the end of the year, marking what it says is a significant milestone in bringing Ketamir-2 closer to clinical trials.

Ketamir-2 is designed to overcome the challenges of existing ketamine treatments by creating an agent that is more targeted. Ketamir-2 selectively inhibits the NMDA receptor at the PCP-binding site with 30 to 50 times lower affinity than traditional ketamine. This selective inhibition can reduce the risk of dissociation and hallucinations, providing a cleaner, safer therapeutic experience for patients. 

Preclinical studies have so far found that Ketamir-2 offers a superior safety profile compared to traditional ketamine. MIRA Pharmaceuticals said one of the most significant findings is that Ketamir-2 does not induce hyper-locomotor activity – a behavior associated with psychotic symptoms – making it a potentially safer option for patients.

Better Oral Absorption Could Be Game-changing 

Another discovery MIRA Pharmaceuticals reports, is Ketamir-2's non-substrate status for P-glycoprotein (P-gp), a membrane protein that typically limits drug entry into the brain. This means that Ketamir-2 can more effectively cross the blood-brain barrier, leading to better oral absorption and higher efficacy at lower doses. This feature is particularly important for patients seeking convenient, at-home treatment options.

On top of all that, MIRA Pharmaceuticals says Ketamir-2's principal metabolite, Nor-Ketamir,  boasts nearly 100% oral bioavailability and sustained plasma residence. This means that once Ketamir-2 is administered orally, it is efficiently metabolized into Nor-Ketamir, which remains in the bloodstream longer, providing extended therapeutic effects. The development of Ketamir-2 Pamoate, a new salt form, further enhances these benefits by ensuring higher plasma and brain levels with a longer half-life, reports the company.

Treating Chronic Pain Too 

Beyond depression and mental health issues, MIRA Pharmaceuticals said studies are 

ongoing to assess Ketamir-2's effectiveness in treating neuropathic pain, a chronic and debilitating condition that has an estimated prevalence of 6.9% to 10% worldwide. The dual potential of Ketamir-2 to address both mental health disorders and neuropathic pain could represent a significant advancement in patient care, offering a versatile and effective treatment option.

The potential of Ketamir-2 and Nor-Ketamir to offer effective, at-home treatment options for mental health disorders and neuropathic pain could prove to be a game-changer. The convenience of oral administration, combined with the drug's safety and efficacy, could significantly improve patient adherence to treatment and overall outcomes. Further, the company says toxicology studies have validated Ketamir-2's safety profile, with no observed toxicity at very high doses in animal models. 

Ketamine holds a lot of promise in treating mental health but the side effects are limiting adoption. Ketamir-2 could change that by addressing the limitations of traditional ketamine and offering a safer, more effective alternative. If the preclinical trials are any indication, Ketamir-2 could provide hope for many sufferers. For more information about MIRA Pharmaceuticals and its novel compounds, visit MIRA Pharmaceuticals.

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