Midatech Pharma Poitive Study Results for OpsiSporin

Midatech Pharma recently announced positive results from a proof-of-concept in vivo study with OpsiSporin, a sustained-release treatment for uveitis.

Uveitis is an inflammatory process affecting the iris, the ciliary body, the choroid layer, or all or part of these structures of the eye. Whilst treatments exist, including corticosteroids and the immunosuppressant compound Cyclosporin A (CsA), a therapeutic that permanently controls inflammation, with a good short- and long-term safety profile, has yet to be developed.

OpsiSporin applies Midatech’s Q Sphera microencapsulation technology platform to precisely encapsulate CsA within polymer microspheres for sustained and extended release. The product has the potential to offer an effective alternative to steroids for the treatment of uveitis and a concomitant reduction in associated adverse effects, such as cataracts and glaucoma.

The in vivo preclinical study sought to determine the efficacy of OpsiSporin microspheres following a single intravitreal injection, in the treatment of autoimmune uveitis, compared with oral administration of CsA, an intravitreal microsphere suspension vehicle and untreated controls. Intravitreal injection, a technique by which a drug is injected into the eye, has become a common method of treatment for many retinal diseases, including AMD, Diabetic Retinopathy, and Retinal Vein Occlusions.

Results of the study showed a significant reduction in the severity of the disease when intravitreal injection with 4.5 micrograms OpsiSporin was compared with microsphere suspension vehicle. The study also demonstrated a comparable reduction in severity when a single intravitreal injection of 4.5 micrograms OpsiSporin was compared to the daily oral administration of 6.7 mg/kg/day CsA (a dose more than one thousand-fold greater). These results show the potential of OpsiSporin to offer patients with autoimmune uveitis a therapeutic alternative to steroids and CsA with high efficacy and reduced adverse effects.

“The positive outcome of this proof-of-concept study is an important step forward in the development of a sustained-release treatment for uveitis,” said Dr. Jim Philips, CEO of Midatech Pharma. “The results showed OpsiSporin to be as efficacious as orally administered CsA at one thousandth of the dose, highlighting the significant value our microencapsulation technology can add to existing therapeutic molecules. We now look forward to progressing this product program to the next stage with the aim of beginning clinical development as early as 2016.”

Midatech Pharma is a nanomedicine company developing and commercializing multiple therapeutic products to enhance the delivery of medicines in major diseases with high unmet medical needs. The Group has a strong pipeline of product candidates in clinical and preclinical development with a clear focus on the key therapeutic areas of diabetes, cancer, and neurological/ophthalmological diseases.

Central to Midatech’s business are two platform technologies that may be used alone or potentially in combination and are designed to enable the targeted delivery (right place) and controlled release (right time) of existing drugs. Midatech’s core platform is a pioneering drug conjugate delivery system based on gold-nanoparticles (GNPs) combined with existing drugs for targeted release at specific organs, cells, or sites of disease. The Group’s secondary platform (acquired through the acquisition of Q Chip) involves the consistent and precise encapsulation of active drug compounds within polymer microspheres that are designed to release the drug into the body in a highly controlled manner over a prolonged period of time. For more information, www.midatechgroup.com.