Building upon Infant Bacterial Therapeutics AB’s (IBT) distinctive experience in growing therapy options for preterm infants, IBT is at an early stage of investigating the probabilities of growing a drug to forestall retinopathy of prematurity, a rising and critical situation that always results in blindness amongst prematurely born infants. The FDA granted orphan drug designation for IBT’s product on Sep 20th .
Retinopathy of prematurity impacts 50-70% of preterm infants weighing lower than 1,500 grams at delivery, in a number of circumstances resulting in sufferers turning into legally blind. Current remedies don’t sufficiently deal with the medical want with extreme circumstances rising considerably from 1.7 to 14.8 per 1,000 preterm infants between the years 1990 and 2011.
Orphan medication are both medication or biologics supposed for the therapy, prognosis or prevention of uncommon ailments or issues affecting lower than 200,000 sufferers within the US per yr. An orphan drug designation qualifies the corporate making use of for it to obtain sure advantages from the US authorities, reminiscent of tax reductions and long run market exclusivity, in trade for growing the drug.
The approval doesn’t change the usual regulatory necessities and processes for acquiring advertising approval for a product. Consequently, all facets of the event should be investigated, together with the medical security and efficacy documentation required for a market authorisation.
The drug candidate is a dipeptide developed beneath the management 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.
“Advances in neonatal intensive care include survival of extremely preterm infants that are highly susceptible to retinopathy of prematurity (ROP), a major cause of blindness in children. Current treatment strategies are based on prevention of progression once an early stage of the disease is diagnosed. These are invasive and involve interventions that are often difficult for these infants to tolerate. Studies in animal models of retinopathy support the preventative potential of arginyl-glutamine dipeptide. Our goal is to determine whether this agent can be provided at a stage that will prevent even the early onset of this disease, thereby eliminating or decreasing the need for future invasive procedures and most importantly, progression to blindness”, says Professor Josef Neu.
“We are honored to be working with Professor Josef Neu on this initiative and pleased that the FDA has granted the product orphan drug designation. We are now investigating if, and how, we can contribute to the care of these patients. IBT has established unique competencies by pursuing treatment solutions for preterm infants, new pathways through pharma grade probiotics as well as enabling a healthy microbiome across the gastroenterology field. These competencies allow us to assess potential portfolio expansion opportunities. Retinopathy of prematurity aligns with our core focus in developing the drug candidate IBP-9414, for the prevention of necrotizing enterocolitis (“NEC”) and enchancment of feeding tolerance in untimely infants. We proceed to anticipate to finish IBP-9414 recruitment with present capital and are concurrently investigating this new alternative with minimal monetary publicity”, says Staffan Strömberg, Chief Executive Officer, IBT.
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Staffan Strömberg, Chief Executive Officer
