The US Food and Drug Administration (FDA) has approved the Bridge Biotherapeutics’ Investigational New Drug (IND) application for BBT-176, used in the treatment of non-small cell lung cancer (NSCLC).

BBT-176 is an epidermal growth factor receptor that works by inhibiting tyrosine kinase (EGFR-TKI), to inhibit EGFR with C797S mutations, which occur after treatment of NSCLC using Tagrisso (osimertinib).

Lung cancer is broadly classified into NSCLC and small cell lung cancer (SCLC), where NSCLC contributes to approximately 85% of all lung cancers.

Bridge Biotherapeutics CEO James Lee said: “We are highly proud of the IND clearance of BBT-176, a novel EGFR-TKI inhibiting C797S mutations for NSCLC treatments, by the U.S. FDA and Bridge will take the best-efficient development practices for bringing new treatment options for patients with NSCLC in need of novel therapy.”

Bridge Biotherapeutics will conduct phase I/II clinical trial on BBT-176 for NSCLC

Korea Research Institute of Chemical Technology (KRICT), a research institute run by Korean government has originally discovered BBT-176, and was licensed to Bridge Biotherapeutics in December 2018.

Bridge Biotherapeutics said that its BBT-176 has demonstrated strong anti-tumour efficacy in the pre-clinical studies of C797S triple mutations, and has enhanced efficacy when used along with anti-EGFR antibodies.

The company is planning to initiate a dose-escalation study in Korea as part of phase I/II study to evaluate BBT-176 for determining the maximum tolerated dose (MTD), along with safety, tolerability and anti-tumour efficacy in the patient groups with an advanced stage of the disease.

In addition, the company intends to carry out a dose-expansion study, as the second part of the trial, to evaluate the safety, tolerability and efficacy along with the best MTD of the drug candidate, in the US and Korea.

Bridge Biotherapeutics is a biotech firm that discovers and develops therapeutics, addressing unmet needs in the areas of ulcerative colitis, fibrotic diseases, and cancers.