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MonoSol Rx Announces Initiation of Phase 2a Trial for Oral Insulin Film

Midaform® Insulin PharmFilm® delivers Insulin through Buccal Soluble Film

WARREN, N.J., July 27, 2015 — MonoSol Rx, the developer of PharmFilm drug delivery technology, with its partner Midatech Pharma, announced today that it has initiated a Phase 2a study for Midaform® Insulin PharmFilm®, MSL- 001, with the dosing of its first patient. Unlike traditional insulin injections, Insulin PharmFilm, the proprietary nanoformulated transbuccal insulin film product delivers insulin through the use of a rapidly dissolving mucoadhesive film that is placed on the inside of the cheek.

The trial is an open label, cross-over, seven arm study with the drug being delivered to patients via a buccal soluble film. The objectives of the study are to establish the pharmacodynamic and pharmacokinetic profile and safety and tolerability for MSL-001 in comparison to subcutaneous administered human recombinant insulin (Humulin).

The study is being conducted in Perth, Australia, with a total of 12 patients, male and female, aged 18 to 55 from a screening pool of up to 35 subjects. The Company expects the study to be completed within five months.

The Phase 1 trial showed that Midaform Insulin PharmFilm was safe and well tolerated at all dose levels tested.

MSL-001 was invented by MonoSol Rx and Midatech and is being developed by their joint venture, MidaSol Therapeutics. The product contains recombinant human insulin, which is non-covalently bound to glycan-coated gold nanoparticles and embedded in an oral, mucoadhesive, polymeric film for transbuccal delivery.

Keith Kendall, Chief Executive Officer said, “We continue to be excited about the prospects of our oral insulin product and the medical need it solves for patients that have long sought a needle-free insulin delivery.”

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to develop products which address the unmet needs of patients. PharmFilm® is designed to benefit patients by improving the safety, efficacy, compliance and convenience of new and currently marketed drugs. The Company’s leadership in film drug delivery is supported by strong intellectual property, a pipeline of prescription formulations based on PharmFilm® technology, and two 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 sublingual film product for the treatment of opioid dependence. For press releases and other company information visit www.monosolrx.com.

About Midatech:

Midatech is a nanomedicine company focused on the development and commercialisation of multiple, high-value, targeted therapies for major diseases with unmet medical need. These diseases include diabetes, rare cancers including brain (glioblastoma), ovarian, liver and pancreatic cancer and neurological/ophthalmologic conditions. Midatech’s strategy is to develop its products in-house in rare cancers and with partners in other indications, and to accelerate growth of its business through strategic acquisition of complementary products and technologies.

All of Midatech’s product candidates derive from its two multi-applicable platform technologies that can be used alone or in combination to enable the targeted delivery (‘right place’) and controlled release (‘right time’) of existing drugs. These technologies are provided through its wholly-owned subsidiaries, Midatech and Q-Chip (acquired in 2014).

Midatech’s core platform is a drug conjugate delivery system based on a patented form of gold nanoparticles (GNP) combined with existing drugs for the safe and targeted release of therapeutic payloads at specific organs, cells or sites of disease.

The Group’s second platform is a sustained release technology acquired with Q Chip that involves the consistent and precise encapsulation of active drug compounds within polymer microspheres enabling their release into the body in a highly controlled manner over a prolonged period of time.

The Group is headquartered near Oxford, UK, with a nanoparticle manufacturing operation in Bilbao, Spain and an R&D facility in Cardiff, UK.

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