Midatech and MonoSol Rx : Positive Phase 1 Clinical Results for their Novel Transbuccal Oral Insulin Film Product

3 May 2012 – Midatech Ltd., a global leader in the design, synthesis and manufacture of nanomedicines based on its passivated gold-nanoparticle technology, and MonoSol Rx LLC, the developer of PharmFilm® drug delivery technology, 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... [PDF] Midatech's Press Release - MonoSol Rx's Press Release -