Results

Bridge Biotherapeutics Inc.

07/21/2022 | Press release | Distributed by Public on 07/21/2022 01:58

Material Management Information related to Judgment of Investment (US FDA approval of BBT-877 phase 2 clinical trial plan for the treatment of Idiopathic Pulmonary Fibrosis (IPF))

Material Management Information related to Judgment of Investment
1. Title US FDA approval of BBT-877 phase 2 clinical trial plan for the treatment of Idiopathic Pulmonary Fibrosis (IPF)
2. Details ※ Investor Notes
The probability that a drug in clinical trial stage will become approved is known to be about 10%, statistically. In the process of clinical trials and marketing authorization, the result may not meet the expectations. Accordingly, there is the possibility that we may change the commercialization plan or discontinue the project. Investors are advised to invest prudently by considering the comprehensive investment risks disclosed through occasional disclosures and business reports.

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.
3. Date of Occurrence(or Date of Confirmation) 2022-07-21
4. Decision Date 2022-07-21
- Attendance of Outside Directors Present(No.) -
Absent(No.) -
- Attendance of Auditors (members of Audit Committee) -
5. Other references useful for making invest decisions
"3. Date of Confirmation is the date of receipt of the relevant response from CRO based on Korean time.
※ Title and date of other disclosure related to this one 2022-07-21 Material Management Information related to Judgment of Investment(특발성 폐섬유증 치료제 미국 FDA의 BBT-877 2상 임상시험 계획 승인 )