Bridge Biotherapeutics Announces Interim Results of Phase 1 Clinical Trial for 'BBT-176'

Partial Response Confirmed in Two Subjects

[Asia Economy Reporter Lee Gwan-joo] Bridge Biotherapeutics announced on the 19th the interim results of Phase 1 clinical trial for the non-small cell lung cancer (NSCLC) treatment candidate 'BBT-176,' confirming cases of 'partial response' where cancer cells partially decreased by more than 30% in two subjects.

This clinical trial is a Phase 1 study conducted at three institutions in Korea, targeting patients with advanced NSCLC who show disease progression due to resistance to existing targeted anticancer treatments, to evaluate antitumor efficacy, tolerability, and safety.

According to the company, among the 16 cumulative subjects, six have taken BBT-176 for more than one cycle (6 weeks) without further disease progression or are currently continuing the medication. Two subjects were observed radiologically to have tumor size reductions of 51% and 30%, respectively, confirming partial response (PR) cases.

The patient with the largest tumor size reduction (51%) is a triple mutation carrier including C797S. The company explained that significant antitumor activity was confirmed in C797S-positive triple mutations targeted by BBT-176, and the patient has been on the drug for 141 days.

The company plans to apply for an 'End of Phase 1 Meeting' with the U.S. Food and Drug Administration (FDA) after completing Phase 1 and proceed to the Accelerated Approval stage based solely on Phase 2 results.

Vice President Lim Jong-jin said, “In the absence of treatments for resistance emerging after third-generation targeted anticancer therapies, it is encouraging to evaluate the antitumor efficacy and tolerability of BBT-176 targeting the C797S triple mutation,” adding, “We plan to pursue various strategies such as FDA accelerated approval to provide hope to terminal lung cancer patients with no treatment alternatives through rapid entry into subsequent clinical trials.”

This content was produced with the assistance of AI translation services.