Midatech & MonoSol Rx Announce Positive Results for Transbuccal Oral Insulin Film

Midatech Ltd. and MonoSol Rx LLC recently announced positive bioavailability and pharmacokinetic results from a first-in-human Phase I clinical study of their Midaform Insulin PharmFilm product in 27 healthy volunteers. The companies have licensed to their joint venture company, MidaSol Therapeutics LLC, 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.

Insulin, stabilized on a nanoparticle and delivered transbuccally, has the potential to offer diabetic patients a viable oral alternative to injectable insulin. The Phase I 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. Fritz R. Buhler, Chief Medical Officer and member of the Board of Midatech Ltd.

“These results are as good as we could have hoped for in terms of insulin bioavailability and pharmacokinetics following administration of Midaform Insulin Pharmfilm,” said A. 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. Based on the success of this in-man study, which unequivocally validates the utility of our diverse preclinical animal models, we look forward to accelerating the entire product development program.”

“The success of Midaform Insulin PharmFilm demonstrates its safety, tolerability, and potential use in treating diabetes, particularly meal-dependent hyperglycemia,” added Professor Thomas Rademacher, CEO and Chairman of Midatech. “This study is a significant step forward for the commercialization of this novel, non-injectable insulin formulation. This trial shows the success of the MidaSol Therapeutics LLC joint venture between Midatech and MonoSol, and brings us closer to using nanomedicines in clinical practice.”

MidaSol Therapeutics LLC. is a joint venture formed by Midatech Ltd. of Oxford, England, and MonoSol Rx LLC of Warren, NJ. The JV company is dedicated to the development of new products for the treatment of diabetes, including existing therapeutics, such as insulin and GLP-1, as well as new molecules. The JV utilizes proprietary technology of the parents in the fields of nanoparticles sourced from Midatech (Midaform) and film technology from MonoSol Rx (PharmFilm). All partnering for development and commercialization in the field of diabetes will be through MidaSol Therapeutics LLC, which is being advised by Ferghana Partners, a specialist investment bank in the biotech field.

Midatech Ltd., UK, is a world leader in the design, synthesis, and manufacture of glycan-coated biocompatible gold-nanoparticles. These nanoparticles can be used to create a wide variety of products with novel characteristics, functions, and applications for a number of industry segments, including life sciences, electronics, and fine chemicals.

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm technology to deliver drugs in films. PharmFilm is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The company’s leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription drug products, a pipeline of prescription formulations based on PharmFilm technology, and two recent FDA approvals – Zuplenz, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone sublingual film, the first combination sublingual film product for the treatment of opioid dependence. For more information visit www.monosolrx.com.