BOONTON, N.J., July 13, 2016 /PRNewswire/ -- Enteris BioPharma, Inc., a biotechnology company developing innovative drug products built around its proprietary delivery technologies, announced today the initiation of its clinical program for Tobrate™, an oral tablet formulation of tobramycin, for the treatment of uncomplicated urinary tract infections (uUTIs). Tobrate™ utilizes the Company's proprietary Peptelligence™ platform, a novel formulation technology that enables oral delivery of molecules that are typically injected, including peptides and BCS class II, III, and IV small molecules.
"Initiation of the Tobrate™ clinical program is a significant event for Enteris as we now have the opportunity to advance a potentially high-value and highly differentiated therapeutic for the treatment of uUTI, a condition that affects approximately 10 million U.S. women each year," said Joel Tune, chief executive officer and executive chairman of Enteris. "Moreover, Tobrate™ is an expansion of our internal drug pipeline, which includes Ovarest™, a Phase 2a ready oral peptide for endometriosis."
As detailed in the Investigational New Drug (IND) application, which was accepted by the U.S. Food and Drug Administration (FDA) in April, Tobrate™ will initially be evaluated in a randomized, double-blind, single ascending dose/multiple ascending dose (SAD/MAD) Phase 1 pharmacokinetic (PK) study in 24 healthy volunteers. Data from the Phase 1 study is expected in the first quarter of 2017.
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