Midatech and MonoSol Rx Announce Positive Phase 1 Clinical Results
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Midatech Ltd. and MonoSol Rx LLC have 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.
Insulin, stabilized on a nanoparticle and delivered transbuccally, has the potential to offer diabetic patients a viable oral alternative to injectable insulin.
The Phase 1 study established Midaform Insulin PharmFilm as a safe, novel, non-injectable insulin delivery system, which closely mimicked the delivery characteristics of monomeric insulin from the pancreas.
Importantly, MidaSol’s product showed a faster onset of action compared to subcutaneous insulin.
Top-line results, including PK and bioavailability elements, from the study will be presented at the European Summit for Clinical Nanomedicine (CLINAM) in Basel, Switzerland by Prof. Dr. med. Fritz R. Bühler, Chief Medical Officer and member of the Board of Midatech Ltd.
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.”
Professor Thomas Rademacher, CEO and Chairman of Midatech, remarked: “The success of Midaform Insulin PharmFilm demonstrates its safety, tolerability and potential use in treating diabetes, particularly meal-dependent hyperglycemia. This study is a significant step forward for the commercialization of this novel, non-injectable insulin formulation. This trial shows the success of the MidaSol Therapeutics LLC joint venture between Midatech and MonoSol, and brings us closer to using nanomedicines in clinical practice.”
