Positive Phase 1 results for transbuccal oral insulin product

Midatech, a UK manufacturer of nanomedicines based on its passivated gold-nanoparticle technology, and MonoSol Rx, the US developer of PharmFilm drug delivery technology, have announced positive results from a first-in-human Phase 1 clinical study of their Midaform insulin PharmFilm product in 27 healthy volunteers.

In January, the firms licensed to their joint venture company, MidaSol Therapeutics, a proprietary nanoformulated transbuccal insulin film product, which delivers monomeric insulin using a rapidly dissolving mucoadhesive film that is placed inside the cheek. They say it offers an oral alternative to injectable insulin.

The clinical study established Midaform Insulin PharmFilm as a safe, non-injectable insulin delivery system, which closely mimicked the delivery characteristics of monomeric insulin from the pancreas. MidaSol’s product showed a faster onset of action compared with subcutaneous insulin, the firms say.

‘These results are as good as we could have hoped for in terms of insulin bioavailability and pharmacokinetics,’ said Mark Schobel, co-president and ceo of MonoSol Rx.

‘The rapid onset of action surpassed our expectations and we look forward to further clinical development of this exciting and new groundbreaking product.’

Professor Thomas Rademacher, ceo and chairman of Midatech, added: ‘This study is a significant step forward for the commercialisation of this novel, non-injectable insulin formulation.’