Premature infant and child nutrition company Nutrinia has raised $12 million from Pontifax, OrbiMed, and the Jacobs family, sources inform Globes. Nutrinia has developed ingestible insulin. The delivery of insulin to the intestine makes intestinal maturation possible, which improves the absorption of nutrients in it. This makes it possible, according the companys previous results, to disconnect premature infants and children who have undergone intestinal-shortening surgery from intravenous feeding sooner.
In the trials conducted by the company thus far, it has demonstrated that its product makes it possible to shorten the duration of premature infants dependence upon intravenous feeding as a primary nutrition source by 4-9 days, and to shorten the duration of their hospitalization in the neonatal intensive care unit (NICU) by 7 days. Nutrinia CEO Michal Olshansky explains that intravenous feeding is far from providing complete nutrition, because most of the vital materials are not absorbed by the body. This matter is critical for preemies and children. Previous studies have shown that faster transitions from intravenous feeding to regular feeding can reduce complication common among preemies, such as blindness and deafness, and improve IQ as much as from 90 to 110. The second target market, children who have undergone intestinal surgery, are hospitalized for an average of 146 days, and mortality rates are in the double digits. The delivery of insulin to the intestine can improve the absorption of substances even if the intestine has been shortened.
The funds raised will be used by the company for two Phase III clinical trials of its product – one with premature infants, and the other with children who have undergone intestinal surgery. The two trials are scheduled to begin 2015. The companys products will be registered for sale using the shortened b5052 protocol, because insulin is a molecule that is familiar to the human body, and is found in mothers milk. Regulators in the US and Europe have agreed for the trials on the two groups to be conducted in parallel. The company plans for the two products to reach market in 2018, and to be registered as orphan drugs, with the special exclusivity given to products for children.
Olshansky says that the company examined the possibility in the past of marketing its products as medicinal food. One of the primary investors in the company was Maabarot, manufacturer of Materna baby formula, which was later sold to Nestle. These two entities could have helped market the product had it been registered as a medical product. However, it was ultimately decided to develop it as a drug, due to the assumption that doctors would feel more comfortable prescribing something that is regulated as a drug. Either way, all the preemie nutrition products are manufactured according to GMP standards, like drugs, and our product is as well, says Olshansky. The decision to go in the drug direction opened the door for the current investments from Pontifax and OrbiMed.
Nutrinia was founded by Professor Naim Shehadeh head of Pediatric Diabetes Clinic at the Rambam Medical Center in Haifa, at the NGT incubator in Nazareth, which was supported by the Jacobs family, who invested in the companys earlier investment round along with Maabarot.
Published by Globes [online], Israel business news – www.globes-online.com – on December 8, 2014
Copyright of Globes Publisher Itonut (1983) Ltd. 2014