Anti-inflammatory drug IML (project company Forbos, LLC)
IML is based on a new molecule, a prodrug which is hydrolyzed in the organism by esterases, producing the active agent (indomethacin) and menthol. Indomethacin is one of the most potent NSAIDs, which combines potent anti-inflammatory, analgesic and antiviral properties (including inhibition of coronaviruses SARS-CoV-1 and SARS-CoV-2). Menthol also has anti-inflammatory and antiviral activity as well as protective action towards gastrointestinal mucosa, liver and kidneys.
Thanks to the high activity of esterases at an inflammation site, high active agent concentration is achieved there (targeted delivery). Thanks to low activity of esterases in the blood, active agent concentration also remains low, minimizing systemic adverse effects, inherent in NSAIDs. As a result, IML has both high safety and efficacy.
Dosage form – hard gelatin capsules for oral administration. IML substance is prepared by simple one stage synthesis. The drug is manufactured using an original but technologically simple formulation based on SEDDS technology (self-emulsifying system), which ensures high bioavailability and long-term maintenance of effective concentration of the active agent in the body. Samples of other promising dosage forms (suppositories, ointments, gels) have been developed.
Patent profile: patented in Russia, foreign patenting is ongoing.
Indications of use:
– Inflammatory and degenerative diseases of the musculoskeletal system (osteoarthritis, rheumatoid arthritis, gout, ankylosing spondylitis, dorsopathy), where long treatment courses with low risk of dangerous side effects are necessary;
– Pain syndromes in trauma and surgery, in otolaryngology and dentistry, neurological diseases;
– COVID-19 – to prevent cytokine storm, pneumonia and ARDS, and to block virus replication.
Main advantages:
– unique combination of pharmacological effects – anti-inflammatory, analgesic and antiviral action;
– strong and prolonged (at least for a day) anti-inflammatory and analgesic effect after single administration;
– absence of adverse toxic effects on the gastrointestinal tract (irritation, ulceration, bleeding) in repeated use in a wide range of doses (due to these side effects, the use of other NSAIDs is limited to short courses and a narrow range of doses, which does not allow to achieve the desired treatment efficacy);
– low risk of other systemic side effects, typical for NSAIDs, towards the liver, kidneys, cardiovascular system, as well as other organs and systems.
Current status: Substance and dosage form are developed; samples for preclinical studies are produced at a licensed pilot production facility; stability of the substance and dosage form during storage is confirmed. Preclinical studies of efficacy, safety and pharmacokinetics are being finalized.
Video: https://youtu.be/yDf8DRG_Lbg