Bridge Biotherapeutics said Monday that the U.S. Food and Drug Administration has cleared the investigational new drug (IND) application for BBT-877, a potent best-in-class drug candidate for Idiopathic Pulmonary Fibrosis (IPF).
The company won a license 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 demonstrated the best-in-class opportunity in comparison to a current development pipeline compound.
Bridge Biotherapeutics will conduct a phase 1 clinical trial through Celerion, an early clinical contract research organization (CRO), in the U.S., to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug candidate in healthy volunteers from the start of next year, the company said.
The planned study will include two phases, a single ascending dose (SAD) phase with five cohorts and a multi ascending dose (MAD) phase with three cohorts. The company expects to finish the phase 1 clinical trial by the end of 2019.
"We are proud of the IND clearance for BBT-877, which has shown a strong potential to be developed as the best-in-class Autotaxin inhibitor for IPF treatment,” said Lee Gwang-hee, head of Translational Research at Bridge Biotherapeutics. “Our team will continue to focus on developing a breakthrough drug to address huge unmet medical needs in IPF.”
Bridge Biotherapeutics also expects to receive orphan drug designation from the FDA early next year, which will also help accelerate the development of the drug, he added.
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