MonoSol Rx, a provider of PharmFilm drug delivery technology, and Midatech, which produces nanomedicines using its passivated gold-nanoparticle technology, have released positive Phase 1 clinical study results on bioavailability and pharmacokinetics of their Midaform Insulin PharmFilm product.
MidaSol Therapeutics, a joint venture between MonoSol Rx and Midatech, has licensed a proprietary nanoformulated transbuccal insulin film product from the two companies. The nanoformulated product uses a rapid-soluble mucoadhesive film to deliver monomeric insulin.
Transbuccal delivery of insulin stabilized on nanoparticles is a feasible oral option for diabetic patients when compared to injectable insulin. The first-in-human Phase 1 study results confirmed that the Midaform Insulin PharmFilm is a safe non-injectable insulin delivery system that imitates the delivery qualities of monomeric insulin secreted from the pancreas. Notably, MidaSol's product started its action quicker than subcutaneous insulin.
MonoSol Rx’ Co-President and Chief Executive Officer, A. Mark Schobel stated that the study results of Midaform Insulin Pharmfilm were up to the expectations in terms of pharmacokinetics and bioavailability of insulin. The quick start of action exceeded the company’s expectations and will continue the product’s clinical development.
Midatech’s Chairman and Chief Executive Officer, Thomas Rademacher commented that the positive results of Midaform Insulin PharmFilm illustrate its tolerability, safety and efficacy in diabetes treatment, especially meal-dependent hyperglycemia, and realize the commercialization of this non-injectable insulin nanoformulation. This study is an important step forward for utilizing nanomedicines in clinical practice.
Midatech’s Chief Medical Officer, Fritz R. Buhler will present the Study findings, including bioavailability and PK elements, at the European Summit for Clinical Nanomedicine in Basel, Switzerland.