The new chemical entity is being analysed as a potential treatment option for depression with suicidal thoughts and refractory depression. Credit: Aonprom Photo / Shutterstock.com.

MIRA Pharmaceuticals has signed an exclusive licensing agreement with MIRALOGX for the development and marketing of Ketamir-2 for depressive disorders. 

The deal encompasses territories including the US, Canada and Mexico.

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MIRALOGX will provide a line of credit of $3m to finance Ketamir-2’s initial development.

An oral ketamine analogue, the new chemical entity is being analysed as a potential treatment option for depression with suicidal thoughts and refractory depression.

This patent-pending compound may offer quick antidepressant effects as soon as four hours after dosing.

In a scientific assessment, the US Drug Enforcement Administration concluded that Ketamir-2 is not a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations, unlike ketamine. 

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The company will develop Ketamir-2 for usage in the at-home setting as a substitute for Spravato, which should be taken under medical supervision.

MIRA president and chief scientific officer Dr Adam Kaplin stated: “Unlike ketamine, which necessitates intravenous, intramuscular, or intranasal administration due to its limited oral bioavailability, in initial pre-clinical studies, Ketamir-2 appears to exhibit a more clinically desirable gastrointestinal absorption profile. 

“In addition, Ketamir-2’s targeted design removes its interaction with some of the receptors targeted by ketamine, such as the opiate receptor, which are believed to be key to mediating some of its key side effects, thus potentially enhancing Ketamir-2’s safety and tolerability profile.

“By focusing on such receptors, Ketamir-2 is designed to possibly mitigate prevalent side effects such as sedation, addiction, dissociative symptoms and cardiovascular concerns.”