Safety and Efficacy of C31G for Ocular Infections

Bax, Richard

Abstract

Bacterial and viral conjunctivitis are extremely common conditions and can result in a wide range of pathologies. There are different manifestations of disease with complications, which occur rarely; however, because the infection is so common, alternative therapies are required. A broad-spectrum non-antibiotic which covers both bacteria and viruses could have great therapeutic utility on a worldwide basis. C31G is a broadly active anti-infective compound with high potency against bacterial and viral pathogens of the eye. C31G is active through surface contact with the pathogen, making resistance development unlikely. Of particular relevance to the eye is the established activity against Chlamydia trachomatis, the leading cause of preventable blindness in the world. C31G has been extensively evaluated in four Phase I clinical studies as a topical vaginal microbicide; however, no effort has been made to evaluate this agent in the eye. Therefore, this SBIR proposes a specific collection of studies to assess the potential of C31G as a treatment for a broad range of bacterial/viral conjunctivitis. Specifically, the aims of this Phase I effort are: (1) conduct an expanded in vitro evaluation of C31G aqueous solutions against primary bacterial and viral isolates that are relevant to ophthalmic infections; (2) assess C31G aqueous solutions for safety and tolerance in the eye in established animal models; and (3) develop candidate ophthalmic formulations of C31G that are appropriate for application in the eye against conjunctivitis caused by bacterial and viral infections. This effort will be primarily conducted at Biosyn; however the animal studies will be conducted with a consortium partner, Louisiana State University Eye Center. Upon achievement of these specific aims, the lead formulation will be advanced through preclinical FDA required studies via a Phase II SBIR.