Dive Brief:
- Israeli company Nutrinia has just raised $30 million in a Series D round of financing. The company has developed an oral insulin formulation that it plans to test in newborns and infants with intestinal malabsorption related to congenital short bowel syndrome (SBS). Nutrinia, which has a U.S. office in Morristown, NJ, will use proceeds from its fundraising efforts to conduct two pivotal clinical trials.
- Nutrinia's oral insulin is different from other approaches to SBS and intestinal malabsorption in that it aims to treat these disorders locally. Clinically the goal is to induce intestinal adaption by delivering a reconstituted powder formulation directly into the gut via cathether, allowing the oral insulin to bind to the receptors in the gastrointestinal tract.
- To date, Nutrinia has raised $43 million. The latest round of financing was led by TPG Biotech, H.I.G. BioHealth Partners and WuXi Healthcare Ventures.
Dive Insight:
Although Nutrinia is one of several companies developing an oral insulin product, it is the only company solely focused on premature babies with intestinal malabsorption. The company's clinical focus is on babies born between 26 and 32 weeks, and infants with congenital short bowel syndrome (SBS). Congenital SBS and intestinal malabsorption are rare, but devastating conditions. Those at risk are babies born prematurely---about 100,000 in the U.S. and the roughly the same amount in the E.U. each year.
For babies born with SBS, parenteral feeding is the norm as clinicians attempt to help these babies survive and eventually thrive. However, the leading cause of death in these babies is not malnutrition per se, but sepsis and infection related to the ever-present feeding tube.
Nutrinia aims to change the treatment paradigm for these infants by using a therapeutic approach that essentially obviates the need for parenteral feeding and hastens intestinal adaptation. There is a clear unmet medical need in this area, which means that if things go well, Nutrinia hopes its therapy will be eligible for orphan-drug designation and accelerated review.
"The biological rationale for Nutrinia’s product is strong and the company’s preclinical data and outcomes of multiple previous clinical trials are compelling. We believe that neonatology, and specifically the NICU, are areas that deserve particular therapeutic development focus, and we are pleased to support Nutrinia’s efforts," said Eran Nadav, partner and MD at TPG Biotech.