Bridge Biotherapeutic announced on Monday that the company has filed an investigational new drug (IND) application to the U.S. Food and Drug Administration, to initiate the phase I study of BBT-877. The drug is a potent best-in-class drug candidate for idiopathic pulmonary fibrosis (IPF) treatment.
The company licensed in BBT-877, an Autotaxin inhibitor from LegoChem Biosciences, the original developer of the drug, in 2017 for exclusive worldwide rights for further development of the drug.
The company presented the results of the preclinical study on BBT-877 at the IPF Summit in August. The data has demonstrated the best-in-class opportunity in comparison to a current development pipeline compound.
The FDA will review the IND application for safety to assure that research subjects will not be subject to unreasonable risks. If the U.S. agency clears the application, the company will conduct a phase 1 clinical trial through Celerion, an early clinical contract research organization (CRO), in the U.S.
BBT-877 showed similar efficacy and safety to GLPG1690, the leading Autotaxin candidate in development by Galapagos, a Belgian company, through pre-clinical efficacy testing in an animal model of bleomycin-induced pulmonary disease mouse, Bridge Bio said.
The Korean company also expects to receive orphan drug designation (ODD) from the FDA early next year, which in turn, will help accelerate the development of the drug.
"We are proud of the IND submission for BBT-877, which has shown a strong potential to be developed as the best-in-class Autotaxin inhibitor for IPF treatment,” said Dr. Lee Gwang-hee, the head of Translational Research at Bridge Biotherapeutics. “We expect to start the first human dosing in healthy volunteers in January 2019.”
If the FDA clears the application, the company will do its best to develop the best-in-class drug to address substantial unmet medical needs in IPF, he added.
LegoChem Biosciences CEO and President Kim Yong-zu also said, “We appreciate Bridge Biotherapeutics’ effort to develop BBT-877in such tremendous energy and speed since the licensing agreement in 2017.”
Bridge Biotherapeutics expects that it will be able to initiate a Single Ascending Dose (SAD) study in the U.S. in January 2019, if it receives IND approval in December.
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