MonoSol Rx, the developer of PharmFilm® drug delivery technology, and Midatech Group Ltd, a global leader and centre of excellence for the design, development, synthesis and manufacture of nanomedicines, today announced positive results from a pre-clinical study of insulin PharmFilm, the first-ever oral insulin film formulation to transbuccally deliver an active therapeutic dose of insulin in a diet-induced diabetic primate model.
The two companies are developing insulin PharmFilm under a partnership that leverages MonoSol Rx's PharmFilm and Midatech's biocompatible nanoparticles to develop orally bioavailable formulations of peptides and drugs. This partnership includes a joint venture set up to focus on the development and commercialization of products combining the two companies' respective technologies in the diabetes field.
The transbuccal Pharmfilm delivery of insulin in this Rhesus monkey study represents the most advanced proof-of-concept to date for any investigative oral buccal insulin formulation, and confirms previously announced positive results in two porcine studies. Primates in the study were administered insulin PharmFilm transbuccally, or "inside the cheek," with data confirming delivery of an active therapeutic dose of insulin.
A spokesperson for MonoSol Rx said, "Diabetes is reaching near epidemic proportions globally. For the millions of patients worldwide who require insulin treatment, an easy-to-administer, orally dissolving insulin formulation that eliminates the need for injection could address the fear and stigma associated with daily insulin injections and may improve patient compliance. While several attempts have been made to orally deliver a therapeutic dose of insulin, insulin PharmFilm has overcome the higher development hurdle and delivered superior proof-of-concept results. Our transbuccal results in primate and porcine models demonstrate the therapeutic potential of our insulin PharmFilm formulation across different species, and we look forward to moving into man in 2011."
In addition to insulin PharmFilm, MonoSol Rx and Midatech are also evaluating additional peptides, including GLP-1, for oral buccal delivery. Based on positive results from the first GLP-1 porcine study, additional GLP-1 studies are being planned for 2011.
A spokesperson for Midatech Group stated, "The results of insulin PharmFilm in our primate study validate the film delivery of active insulin across the buccal mucosa for the first time. In addition, we have preclinical proof-of-concept that these results can be achieved in a controlled dose precisely tailored to suit individual needs. We anticipate results from our human clinical trials, slated to commence in the second quarter of 2011, to revolutionize treatment methods and insulin delivery for diabetics worldwide."