Diabetes is considered the fifth leading cause of death in developed countries with a global prevalence of close to 300 million people and is growing rapidly. This metabolic disease is associated with significant complications such as obesity, high blood pressure, high cholesterol, blindness, premature death due to heart disease and amputations. Through its MidaSol Therapeutics joint venture with Monosol Rx, Midatech is at the forefront of developing medicines that ease patient compliance while ensuring optimal therapeutic efficacy. This technology is being evaluated in this disease area by a major US pharmaceutical company.
Midatech’s most advanced programme takes advantage of the fact that binding a peptide hormone to a nanoparticle allows its absorption across the mucosa of the cheek. This has enabled Midatech and its partner, Monosol Rx, to develop needle-free delivery of insulin for diabetes mellitus. As part of this joint venture, Midatech has combined its unique GNP technology with its partner’s expertise in transitioning pharmaceuticals to film to develop a self-dissolving strip containing nanoparticle insulin referred to as Midaform™ Insulin PharmFilm®. This mode of administration provides a more convenient and discrete form of insulin delivery than injections and has the potential to make injections redundant in the treatment of diabetes.
A more convenient and discrete form of insulin delivery than injections…
From positive Phase I clinical trial results, it was demonstrated that the transbuccal insulin formulation is safe and did not elicit any adverse events or discomfort to the healthy volunteers. PK data was demonstrated to be significant and similar to that of PK data in pre-clinical models. A Phase II trial is planned to start in 2014.
Midatech has successfully bound glucagon-like-peptide [GLP-1] to GNPs for the treatment of Type 2 diabetes mellitus. The company has commenced pre-clinical research in this area and has generated promising early stage results. The current sales for GLP-1 analogues for the treatment of diabetes were US$ 1.6 billion in 2011 and were projected to increase to over $5 billion by 2020.
A combination treatment in which insulin and GLP-1 are delivered on the same nanoparticles has also been developed and showed positive results in pre-clinical studies.
Type 1 Diabetes Immunotherapy
Midatech and its consortium partners have received a €6 million EU Framework 7 grant for the development of an immunotherapeutic vaccine using its GNP technology to intra-dermally administer suppressive T-cell epitopes from autoimmune antigens to counter-act the autoimmune destruction of pancreatic β-cells. The project started in September 2012.