Date: 2012-05-03
Type of information:
phase: 1
Announcement: results
Company: Midatech (UK)
Product: insulin-coated gold nanoparticles (insulin-passivated gold glyconanoparticles (MidaForm™ insulin) formulated into PharmFilm® for buccal delivery)
Action mechanism:
Disease: diabetes
Therapeutic area: Metabolic diseases
Country: Switzerland
Trial details:
Latest
news: * On May 3, 2012, Midatech, 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, have 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, 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. 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.* On November 15, 2011, Midatech has received Swissmedic approval to start the First-in-Human clinical trial with insulin-coated gold nanoparticles, which will be coordinated through its Swiss subsidiary PharMida AG.
The trial is designed to assess the safety profile of insulin-coated gold nanoparticles when applied in transbuccal film to healthy volunteers. The study will be performed in a clinical research unit near Basel, Switzerland and results of the trial are expected during Q1 2012.
Midatech has developed ultra-small gold nanoparticles (GNP, < 2 nm) that act as artificial atoms that are covalently surface-passivated with a mixed carbohydrate/organic layer (corona). The corona is designed to non-covalently bind and stabilise multiple copies of bioactive peptides like insulin and glucagon-like peptide-1 (GLP-1). Extensive pre-clinical studies with GNP and peptide-GNP have demonstrated favourable PK properties and a clean safety profile in studies with single and multiple dosing by oral, intravenous, subcutaneous and transbuccal route in various animal species.
