The United States Food and Drug Administration (FDA) has approved Korea-based Bridge Biotherapeutics Inc's Investigational New Drug (IND) application for BBT-176 on 18 January , it was reported yesterday.

The product is a novel epidermal growth factor receptor - tyrosine kinase inhibitor (EGFR-TKI) and is designed to inhibit EGFR with C797S mutations, which arise as Tagrisso (osimertinib) resistant mutations following Tagrisso treatment in non-small cell lung cancer (NSCLC). In the pre-clinical studies, the product indicated strong anti-tumour efficacy in C797S triple mutations. Furthermore, BBT-176 showcased markedly improved efficacy when combined with anti-EGFR antibodies.

The company is to start a dose escalation study as the first part of the phase I/II study in Korea to find the maximum tolerated dose (MTD) and to observe safety, tolerability and anti-tumour efficacy of the product in the patient groups of advanced NSCLC. In the second part of the study, which will be a dose expansion study, the safety, tolerability and efficacy along with the best MTD of the drug candidate will be evaluated in the United States and Korea.