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1) Title of study:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study to Evaluate the Efficacy, Safety, and Tolerability of BBT-877, as mono- or add-on therapy, in Patients with Idiopathic Pulmonary Fibrosis (IPF)
2) Study phase: Phase II
This study is to evaluate the efficacy, safety, and tolerability of BBT-877 and is planned to be conducted in multi countries, including the U.S, South Korea, Israel, and the EU countries.
3) Disease(indication)
: idiopathic pulmonary fibrosis, IPF
4)IND Submission(approval) date and regulatory authorities
– Clinical trial approval date : 2022-07-21
– Regulatory authorities : FDA
– Institution: Approximately 13 institutions in the U.S (total of 50 sites globally)
5) US IND Number : IND 140199
6) Purpose of the trial
This is a Phase 2 study to evaluate the efficacy, safety and tolerability of BBT-877, as mono- or add-on therapy in patients with Idiopathic Pulmonary Fibrosis (IPF).
7) Conduct of clinical trial
– Number of Subjects: Approximately 120 patients will be randomized.
– Total duration of study participation: up to 34 weeks
Planned screening duration: up to 6 weeks
Planned treatment duration: 24 weeks
Planned follow-up duration: 4 weeks
8) Expected effect
– BBT-877 is a small-molecule compound that suppresses inflammation and sclerosis by reducing LPA production through the selective inhibition of autotoxin.
– The purpose of this study is to explore if there is a disease improvement when BBT is administered as add-on therapy to approved Antifibrotics (AF) and to explore if there is an improvement in the effect and side effects compared to the approved AFs when BBT-877 is administered as monotherapy.
9) Other main points
– Bridge Biotherapeutics, Inc, submitted in-vivo comet assays with TEM evaluation per FDA’s request in response to Type C Meeting conducted in June 2021.
– The results of in-vivo comet assays with TEM evaluation were negative and the final report was included in the submission to FDA.
– After the submission, FDA responded that the overall results of the comet assays are judged to be equivocal.
– FDA requested to accurately describe the findings of two studies in the Investigator’s Brochure, given the clinical indication of IPF and the unmet medical needs.
– Therefore, we have submitted clinical trial documents reflecting the recommendation.
