MIRA Pharmaceuticals and MIRALOGX have formed a new partnership to develop and commercialise oral ketamine analog Ketamir-2, hoping to change the landscape of depressive disorder treatments.
Ketamir-2 is a patent-pending compound under investigation to potentially deliver ultra-rapid antidepressant effects as early as four hours after dosing.
After making its scientific review of Ketamir-2, the DEA concluded that Ketamir-2 is not a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.
The development of Ketamir-2 is being led by Dr Adam Kaplin, MIRA’s President and Chief Scientific Officer, who served as the Johns Hopkins site Principal Investigator for multi-centre pivotal clinical trials, leading to the approval of an intranasal left-handed ketamine molecule Spravato.
Dr Kaplin said: “Unlike ketamine, which necessitates intravenous, intramuscular, or intranasal administration due to its limited oral bioavailability, Ketamir-2 appears to exhibit a more clinically desirable gastrointestinal absorption profile. 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.”
Kaplin believes Ketamir-2 could mitigate prevalent side effects such as sedation, addiction, dissociative symptoms, and cardiovascular concerns. He hopes its predicted favourable side effect profile and its oral availability means Ketamir-2’s can be approved for home self-administration.
Erez Aminov, Chief Executive Officer of MIRA, said: “Ketamir-2 embodies hope, and this partnership propels us toward a future where we may be able to actively address mental health challenges with transformative solutions.”