CMX157 / Hepion Pharma - LARVOL DELTA

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Biosimilar

Development of rectal enema as microbicide (DREAM): Preclinical progressive selection of a tenofovir prodrug enema. (PubMed, Eur J Pharm Biopharm) - "Using a murine model, we compared the plasma and tissue pharmacokinetics of TFV and various TFV prodrugs, including tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), and hexadecyloxypropyl tenofovir (CMX157), after dosing as enema formulations with varying osmolality and ion content. We observed that the enema vehicle composition played a more important role than the TFV prodrug properties in achieving rapid and therapeutically relevant tenofovir diphosphate (TFV-DP) concentrations in mouse colorectal tissue. Our results support the next steps, which are further preclinical (non-human primate) and clinical development of a hypo-osmolar TFV enema product for rectal PrEP."

Journal • Preclinical

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