Bridge Biotherapeutics, a Kosdaq-listed drug development company, said Wednesday that it has received confirmation from the FDA to go ahead with a clinical trial of BBT-301, a candidate for the treatment of idiopathic pulmonary fibrosis (IPF).

The 505(b)(2) application, part of the FDA's new drug applications, is a streamlined pathway that leverages safety and efficacy data from previously approved drugs.

Bridge Biotherapeutics stated that the FDA's response affirmed the suitability of progressing BBT-301 into a phase 2a trial, validating both the clinical overview and the feasibility of the strategy.

BBT-301 is a novel drug candidate for IPF, employing a mechanism of action that selectively modulates a potassium channel recognized for its association with fibrotic diseases.

The company presented key nonclinical data on the efficacy and effectiveness of BBT-301 at the IPF Summit 2022, an international conference on IPF, held in the U.S. last August.

Based on the results of the pre-investigational new drug (IND) meeting, the company plans to quickly prepare an IND process and enter phase 2 clinical trials next year.

"We are pleased to have the FDA confirm the appropriateness of our future development strategy for BBT-301," said James Lee, CEO of Bridge Biotherapeutics. “We plan to successfully advance BBT-301, a treatment for IPF, into clinical trials”.