Sigma-Tau Pharmaceuticals, Inc. and Danisco BioActives announced today that they have signed a partnering agreement for the development of a new biologic drug candidate, which may help to prevent a deadly disease called necrotizing enterocolitis (NEC).
NEC is a rare, life-threatening gastrointestinal disorder in infants that affects very low birth weight (VLBW) premature infants (babies less than 1,500 grams or 3 pounds, five ounces). There are approximately 60,000 VLBW babies born each year in the United States, of which 5 percent to 15 percent will acquire NEC. Treatment options for this condition are extremely limited and mortality rates of 20 percent to 30 percent have gone unchanged in the United States for more than 30 years.
Under the terms of the agreement, Sigma-Tau and Danisco will collaborate to develop STP-206, a biologic agent comprised of live bacteria, which may be effective in preventing the occurrence of NEC. Sigma Tau, manufacturer of VSL#3 will manage the clinical development of the product and, ultimately, will seek the approval of the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) to market the drug for the prevention of NEC. Human clinical trials are scheduled to start later this year.
"We have had a very longstanding and successful relationship with Danisco and we are very pleased to move forward with this agreement," said Gregg Lapointe, chief executive officer of Sigma-Tau Pharmaceuticals. "Together, we hope to provide a new and innovative option to prevent this deadly disease and ultimately save lives."
"Danisco is excited to collaborate with Sigma-Tau Pharmaceuticals in the development of an innovative live biotherapeutic solution to this complex and life-threatening disorder," said Scott Bush, dietary supplements vice president for Danisco BioActives.
What is Necrotizing Enterocolitis (NEC)
NEC is a life-threatening gastrointestinal disorder with significant morbidity and mortality primarily affecting premature infants under 1500 grams, known as very low birth weight infants. Every year, thousands of premature babies die as a result of this disease and more will suffer from abnormal neurodevelopmental outcomes. While the cause of the disease is unknown, the pathological findings of infants who died of NEC show intense mucosal inflammation, hemorrhage and transmural necrosis of the small and large intestines.
In the United States, more than 300,000 premature babies (less than 2500 grams) are born each year. Of this group, the 60,000 to 70,000 that weigh less than 1,500 grams at birth are at high risk for acquiring NEC.
GAITHERSBURG, Md., April 7 - PR Newswire