April 16, 2024

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[THE INVESTOR] Bridge Biotherapeutics said on Nov. 19 it has filed an Investigational New Drug application with the US Food and Drug Administration to initiate phase 1 trials of BBT-877, a potent best-in-class drug candidate for Idiopathic Pulmonary Fibrosis treatment.

BBT-877, an autotaxin inhibitor, originally discovered by Korean biotech firm LegoChem Biosciences, was licensed to Bridge Biotherapeutics in 2017 with worldwide exclusive rights. 

In August, Bridge Biotherapeutics presented the results of its preclinical study on BBT-877 at the IPF Summit, attracting pulmonologists’ interest on its efficacy and safety. The data has demonstrated a best-in-class opportunity in comparison to the current development pipeline of the compound.

“We are proud of the IND submission for BBT-877, which has shown strong potential to be developed as a best-in-class Autotaxin inhibitor for IPF treatment. We expect the first human dosing in healthy volunteers will be initiated in January, if the FDA clears the application. Our team will do its best to develop the best-in-class drug to address huge unmet medical needs in IPF,” stated Lee Gwang-hee, head of translational research at Bridge Biotherapeutics.

“We appreciate our team’s efforts to develop this compound with tremendous energy and speed since the licensing agreement in 2017. This progress exemplifies good collaboration between a discovery-focused biotech and a development-focused biotech in Korea’s vibrant biotech ecosystem,” said CEO and President Yong Zu Kim.

The company expects that it will be able to initiate a Single Ascending Dose study in the US in January if its IND application is cleared by December. In the phase 1 trials on healthy volunteers, safety and tolerability of BBT-877 will be the primary endpoints.

Bridge Biotherapeutics is also developing BBT-401, the first anti-Pellino-1 compound for ulcerative colitis and aims to initiate phase 2 studies in the US within this year.

By Park Han-na (hnpark@heraldcorp.com)