FDA approved Infant Bacterial Therapeutics' request for a New Orphan Drug Designation. Building upon Infant Bacterial Therapeutics AB's (IBT) unique expertise in developing treatment solutions for preterm infants, IBT is at an early stage of investigating the possibilities of developing a drug to prevent retinopathy of prematurity, a growing and serious condition that often leads to blindness among prematurely born babies. The FDA granted orphan drug designation for IBT's product on Sep 20th.

Retinopathy of prematurity affects 50-70% of preterm infants weighing less than 1,500 grams at birth, in several cases leading to patients becoming legally blind. Current treatments do not sufficiently address the medical need with severe cases growing significantly from 1.7 to 14.8 per 1,000 preterm infants between the years 1990 and 2011. Orphan drugs are either drugs or biologics intended for the treatment, diagnosis or prevention of rare diseases or disorders affecting less than 200,000 patients in the US per year.

An orphan drug designation qualifies the company applying for it to receive certain benefits from the US government, such as tax reductions and long term market exclusivity, in exchange for developing the drug. The approval does not change the standard regulatory requirements and processes for obtaining marketing approval for a product. Consequently, all aspects of the development must be investigated, including the clinical safety and efficacy documentation required for a market authorisation.

The drug candidate is a dipeptide developed under the leadership of Dr. Josef Neu, Professor at University of Florida Health, Department of Pediatrics, Division of Neonatology and Dr. Maria Grant, Professor at University of Florida Health, Department of Endocrinology, Diabetes and Metabolism.