Nutrinia’s NTRA-9620 gets FDA orphan status to treat short bowel syndrome

NTRA-9620 is intended to improve post-resection bowel adaptation as well as patient outcomes, which includes reducing reliance on parenteral nutrition support and increasing enteral nutrition intake.

The company intends to initiate a pivotal clinical trial in this indication and the new treatment is expected to help many patients across the world, by reducing their dependence on parenteral nutrition, which puts them at a higher risk for liver disease, infections, and other complications.

Nutrinia CEO Miki Olshansky said: "Receiving Orphan Drug Designation in the U.S. market for the development of our SBS therapy, NTRA-9620, to benefit SBS patients represents a significant milestone for Nutrinia.

"As a first step, we are working closely with leading neonatologists, gastroenterologists and surgeons, as well as U.S.A FDA to finalize the design of our upcoming trial of NTRA-9620 in infants with SBS."

Following its investigational new drug (IND) application, the company intends to launch a US and European multi-national study in this patient population.

Nutrinia also aims to run a separate, concurrent clinical program of NTRA-2112 to treat gastrointestinal (GI) malabsorption caused by intestinal immaturity in preterm infants.

SBS is frequently caused by the surgical removal of a large portion of the small intestine, while additional causes for this disorder in infants are GI-related complications such as necrotizing enterocolitis (NEC), as well as gastroschisis, atresia and other congenital disorders.

The company said that both NTRA-9620 and NTRA-2112 are administered orally and target activation within the local GI tract.