Enteris BioPharma, a privately held API company, launched a clinical program for its oral tablet formulation of Tobrate (tobramycin) designed to be used for the treatment of uncomplicated urinary tract infections.
The FDA accepted Enteris’ Investigational New Drug application for Tobrate in April. Under the Phase I study, the drug will be evaluated in a randomized, double-blind, single ascending dose/multiple ascending dose with 24 healthy patients. The data from the study is expected to be complete in early 2017, the company said.
Uncomplicated UTI’s affect about 10 million women in the U.S. each year, according to Enteris. Tobrate will use the company’s Peptelligence platform that allows oral delivery of molecules that are typically injected.
“We now have the opportunity to advance a potentially high-value and highly differentiated therapeutic for the treatment of uUTI,” Joel Tune, CEO, said in a statement.
Additionally, the company announced it is partnering with RRD International, a product development company, to develop Tobrate. RRD is expected to provide regulatory and clinical development support for the drug through the end of the Phase II meeting with the FDA.
Enteris, which was formed in 2013 and is based in New Jersey, got its start after buying the Peptelligence platform, a nasal delivery technology and the recombinant manufacturing process from Unigene Laboratories.
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