Midatech and MonoSol Rx Announce Positive Phase 1 Clinical Results for their Novel Transbuccal Oral Insulin Film Product
Midatech Ltd. and MonoSol Rx LLC announced positive bioavailability and pharmacokinetic results from a first-in-human Phase 1 clinical study of their Midaform™ insulin PharmFilm product in 27 healthy volunteers. The companies have licensed to their joint venture company, MidaSol Therapeutics LLC, a proprietary nanoformulated transbuccal insulin film product, which delivers monomeric insulin through the use of a rapidly dissolving mucoadhesive film that is placed onto the inside of the cheek.
A. Mark Schobel, Co-President and CEO of MonoSol Rx, said “These results are as good as we could have hoped for in terms of insulin bioavailability and pharmacokinetics following administration of Midaform Insulin Pharmfilm. The rapid onset of action surpassed our expectations and we look forward to further clinical development of this exciting and new groundbreaking product. Based on the success of this in-man study, which unequivocally validates the utility of our diverse pre-clinical animal models, we look forward to accelerating the entire product development program.”
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