BBT-877 / Bridge Biotherap, LigaChem Biosci - LARVOL DELTA

Phase 2 study design and analysis approach for BBT-877: an autotaxin inhibitor targeting idiopathic pulmonary fibrosis. (PubMed, BMJ Open Respir Res) - P2 | "In this phase II, double-blind, placebo-controlled study, approximately 120 patients with IPF will be randomised in a 1:1 ratio to receive placebo or 200 mg of BBT-877 two times per day over 24 weeks, with stratification according to background use of an antifibrotic treatment (pirfenidone background therapy, nintedanib background therapy or no background therapy). The results of this study will be presented at scientific conferences and peer-review publications. NCT05483907."

Clinical protocol • Journal • P2 data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Bridge Bio Announces Topline Results of BBT-877 Phase 2 Clinical Trial [Google translation] (Medipana) - P2 | N=129 | NCT05483907 | Sponsor: Bridge Biotherapeutics, Inc. | "Bridge Biotherapeutics announced the release of top-line data from the global phase 2 clinical trial of BBT-877, a treatment candidate for idiopathic pulmonary fibrosis (IPF), and announced that it failed to confirm a significant improvement in the primary endpoint, the change in Forced Vital Capacity (FVC) at week 24....According to the results, the change in the primary endpoint, Forced Vital Capacity at week 24, was observed in both the drug group and the placebo group, but there was no statistically significant difference between the two groups (p=0.385)."

P2 data • Idiopathic Pulmonary Fibrosis

Bridge Biotherapeutics' stock tumbles after Phase 2 pulmonary fibrosis trial failure (Chosun Biz) - "The stock price of Bridge Biotherapeutics, listed on the KOSDAQ, has been plummeting for two consecutive days following the news that it failed to prove the efficacy of its new drug for pulmonary fibrosis in a Phase 2 clinical trial. As of 9:36 a.m. on the 16th, Bridge Biotherapeutics was trading at 4,400 won, down 1,880 won (29.94%) from the previous trading day. Bridge Biotherapeutics announced on the 14th, after market close, that it did not confirm significant improvement in its Phase 2 clinical trial of ‘BBT-877’ for idiopathic pulmonary fibrosis, a rare disease that causes the lungs to harden and lose function, which can lead to death in severe cases. Following this news, Bridge Biotherapeutics' stock price fell to the lower limit (the lowest price limit for the day) again today, continuing from the previous day."

P2 data • Stock price • Idiopathic Pulmonary Fibrosis

Phase 2 Study Design and Analysis Approach for BBT-877: An Autotaxin Inhibitor Targeting Idiopathic Pulmonary Fibrosis (medRxiv) - "Methods and analysis In this phase II, double-blind, placebo-controlled study, approximately 120 patients with IPF will be randomized in a 1:1 ratio to receive placebo or 200mg of BBT-877 twice daily over 24 weeks, with stratification according to background use of an antifibrotic treatment (pirfenidone background therapy, nintedanib background therapy or no background therapy). The primary endpoint is absolute change in FVC (mL) from baseline to week 24. Key secondary endpoints include change from baseline to week 24 in % predicted FVC, diffusing capacity of the lung for carbon monoxide, 6-minute walk test, patient-reported outcomes, pharmacokinetics and safety, and tolerability."

Clinical protocol • Idiopathic Pulmonary Fibrosis

BBT877-IPF-004: To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF (clinicaltrials.gov) - P2 | N=129 | Completed | Sponsor: Bridge Biotherapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

BBT877-IPF-004: To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients with IPF (clinicaltrials.gov) - P2 | N=129 | Active, not recruiting | Sponsor: Bridge Biotherapeutics, Inc. | Trial completion date: Sep 2025 ➔ Feb 2025

Trial completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

JPMorgan Chaebol Bridge Bio "Business Development Discussion for New Pulmonary Fibrosis Drug 'BBT-877'" [Google translation] (MSN News) - P2 | N=129 | NCT05483907 | Sponsor: Bridge Biotherapeutics, Inc. | "Bridge Biotherapeutics (288330) announced on the 17th that it attended the 43rd JP Morgan Healthcare Conference held in San Francisco, California, USA for four days from the 13th (local time) and concluded business development meetings and corporate presentations with global investors and big pharma....The primary efficacy evaluation index of phase 2 clinical trials, ‘forced vital capacity’ (FVC change), was also introduced as the basis for the estimated efficacy of BBT-877....The representative added that the company plans to conduct a long-term phase 3 clinical trial targeting a large number of patients in collaboration with a global big pharma, and aims to enter the market in the first half of 2026....Top-line data is expected to be available in April."

New P3 trial • P2 data • P2 data • Idiopathic Pulmonary Fibrosis

Bridge Biotherapeutics to present IPF drug candidate at JP Morgan Healthcare Conference (Korea Biomedical Review) - "Bridge Biotherapeutics said Monday that it has been officially invited to present at the 43rd J.P. Morgan Healthcare Conference in San Francisco, California, to be held from Jan. 13 to 16 in 2025....CEO Lee Jung-kue will introduce the company’s major R&D projects, including BBT-877, which is expected to lead to significant licensing agreements. He will also outline the company’s growth strategies, targeting key stakeholders and investors in the pharmaceutical and biotech industries....BBT-877, currently in the later stages of a phase 2 clinical trial across North America, Europe, and the Asia Pacific, is expected to release topline data in April next year. More than 75 percent of the trial’s 98 participants have completed 24 weeks of treatment, with data collection expected to finish in the first quarter of 2025."

P2 data • Trial status • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

[Issue] Bridge Biotherapeutics, “Accelerating Financial Improvement”…Technology Transfer Visible! Second Legacy Also Considered [Google translation] (Pax Economic TV) - "Bridge Biotherapeutics (CEO Lee Jeong-gyu) is expected to improve its financial status as it is able to secure funding. This is because the technology transfer of BBT-877, a candidate for the treatment of idiopathic pulmonary fibrosis under development, is becoming visible. In addition, it is considering a paid-in capital increase through a third-party allocation following the general paid-in capital increase in July. This will likely stabilize its finances while also resolving the risk of being a management stock."

Commercial • Idiopathic Pulmonary Fibrosis

Bridge Biotherapeutics to Spur Global Business Development Discussions at 'BioEurope' (Google translation) (MedigateNews) - "BBT-877, a candidate for the treatment of idiopathic pulmonary fibrosis, which has entered the latter half of phase 2 clinical trials and is working on the final stage, has completed the 24-week administration procedure for 82 out of 129 subjects, and recently received comprehensive recognition for the safety and competitiveness of the drug from the Independent Data Monitoring Committee (IDMC) and recommended that the clinical trial be completed as planned. Topline data is scheduled to be announced in April next year, and many meetings related to the candidate will be held."

P2 data • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

Bridge Bio, IDMC Recommends Continued Clinical Trial of ’BBT-877’ [Google translation] (HIT News) - "Bridge Biotherapeutics...announced on the 10th that it had been recommended by the 4th Independent Data Monitoring Committee (IDMC) held on the 8th (local time in the US) to continue the phase 2 clinical trial of 'BBT-877', a candidate for the treatment of idiopathic pulmonary fibrosis (IPF)...At this meeting, the fourth since the 3rd IDMC held in April, the experts reviewed the efficacy and safety data for all subjects as of September 2 and recommended that the clinical trial proceed as planned without any concerns about the safety and efficacy of the drug, consistent with the results of the previous meeting....With 82 of the 129 subjects participating in this clinical trial having completed the 24-week medication procedure, the company plans to proceed with commercialization through global technology transfer contract negotiations while preparing to announce top-line data in April next year."

DSMB • P2 data • Idiopathic Pulmonary Fibrosis • Pulmonary Disease • Respiratory Diseases

BBT877-IPF-004: To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients with IPF (clinicaltrials.gov) - P2 | N=129 | Active, not recruiting | Sponsor: Bridge Biotherapeutics, Inc. | Trial completion date: Dec 2024 ➔ Sep 2025

Trial completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Bridge Bio to Announce Topline Phase 2 Clinical Trial for Idiopathic Pulmonary Fibrosis Treatment Drug in April Next Year (Google translation) (BioNews) - "Bridge Biotherapeutics (hereafter Bridge Bio) announced that the top line (main results) of the phase 2 clinical trial of 'BBT-877 (development code name),' which is being developed as a treatment candidate for idiopathic pulmonary fibrosis (IPF), will be announced in April next year. Bridge Bio also expressed its intention to produce L/O results as soon as possible, as it is continuing discussions on the ongoing technology export (L/O) of BBT-877 with a pharmaceutical company ranked within the top 10 in the world."

P2 data • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

BBT877-IPF-004: To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF (clinicaltrials.gov) - P2 | N=129 | Active, not recruiting | Sponsor: Bridge Biotherapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Bridge Biotherapeutics stock price soars… Idiopathic pulmonary fibrosis treatment candidate 'BBT-877' draws attention [Google translation] (Pinpoint News) - "The stock price of Bridge Biotherapeutics, a company specializing in innovative new drug research and development, is rising sharply. According to the Korea Exchange on the 31st, it closed at 2,515 won, up 7.02% from the previous trading day. The stock price is off the bottom and is stepping on the accelerator. The completion of patient enrollment in the phase 2 clinical trial for the treatment of idiopathic pulmonary fibrosis appears to have provided a boost to the stock price."

Commercial • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

Bridge Biotherapeutics Announces Completion of Enrollment in the Phase 2a Clinical Study of BBT-877 for the Treatment of Idiopathic Pulmonary Fibrosis (PRNewswire) - "Bridge Biotherapeutics...announced that patient participant enrollment has been completed in the Phase 2 clinical study of BBT-877, a novel autotoxin (ATX) inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF). The Phase 2, multi-center, randomized, double-blind, placebo-controlled study (NCT05483907) aims to evaluate the efficacy, safety, and tolerability of BBT-877 in patients with IPF, with or without anti-fibrotic (AF) approved background therapies (pirfenidone or nintedanib)....A total of 120 patient participants were enrolled from approximately 50 clinical trial sites located in the U.S., South Korea, Australia, Poland, and Israel, representing diversity of ethnicity and race....The Company expects topline data from this study to be announced in the first half of 2025."

Enrollment closed • P2a data • Idiopathic Pulmonary Fibrosis

Bridge Bio, Early Achievement of Phase 2 Patient Enrollment for Idiopathic Pulmonary Fibrosis Treatment [Google translation] (News1 Korea) - "Bridge Biotherapeutics...announced on the 11th that the patient enrollment rate for the global phase 2 clinical trial of its idiopathic pulmonary fibrosis treatment candidate 'BBT-877' has exceeded 95%, significantly getting closer to the original target number of 120. The company expects to complete patient enrollment for the clinical trial next month, more than a month earlier than expected....Bridge Bio is conducting a multinational phase 2 clinical trial of BBT-877 in approximately 50 clinical institutions in five countries: Korea, the United States, Australia, Poland, and Israel. The drug’s efficacy, safety, and tolerability are being evaluated in patients with idiopathic pulmonary fibrosis."

Enrollment status • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

Bridge Bio CEO Lee Jeong-gyu signs a block deal to participate in paid-in capital increase subscription [Google translation] (Newspim) - "According to the industry, Bridge Bio will complete the recruitment and registration of 120 patients in the phase 2 clinical trial of BBT-877 in the second half of this year and is expected to announce the clinical results next year."

Enrollment status • P2 data • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

Bridge Bio "Conducted about 50 meetings at BioUSA… Technology transfer materialized" [Google translation] (News1 Korea) - "Bridge Bio shared the status of phase 2 clinical development and future plans for ‘BBT-877’ (autotaxin inhibitor), a candidate for the treatment of idiopathic pulmonary fibrosis. Currently, more than 100 patients participating in the clinical trial, which is about 85% of the target of 120, are being registered and receiving medication....Bridge Bio reported that it held about 50 business development meetings. It is evaluated that the outline of technology transfer, starting with BBT-877, has become more concrete. Regarding BBT-877, technology transfer and partnering discussions were held with global pharmaceutical and bio companies such as Big Pharma."

Trial status • Idiopathic Pulmonary Fibrosis • Pulmonary Disease • Respiratory Diseases

Bridge Bio goes smoothly with paid-in capital increase process… First issuance price confirmed on the 11th of next month [Google translation] (News1 Korea) - "Bridge Biotherapeutics' paid-in capital increase process is progressing smoothly. The funds secured through capital increase are expected to be used for clinical trials of 'BBT-877'...for idiopathic pulmonary fibrosis. RigaChem Bioscience...is actively considering participating in this paid-in capital increase...Bridge Biotherapeutics announced that it plans to confirm the first issuance price for paid-in capital increase on the 11th of next month. The plan is to set the 14th of the same month as the base date for allotment of new shares through paid-in capital increase...In addition, as the clinical trials of BBT-877 and 'BBT-207', which are making all efforts as key tasks, are progressing smoothly, a capital increase was decided to preemptively secure additional costs...In relation to BBT-877 Phase 2, a total of three IDMC meetings were held....Bridge Bio plans to hold the next meeting in September 2024 to continuously monitor the safety of clinical participants."

Financing • Trial status • Idiopathic Pulmonary Fibrosis • Lung Cancer • Oncology • Solid Tumor

Bridge Bio selected as ‘presenting company’ at 2024 Bio USA for 3 consecutive years [Google translation] (Medipana) - "We plan to share major progress and additional data related to clinical trials. In particular, as the registration of patients in the multinational phase 2 clinical trial of BBT-877 progresses to approximately 75% of the target, discussions on the drug's efficacy and safety are expected to progress further....the company has been selected as a Bio USA presenting company for the third consecutive year and will conduct a company introduction presentation to industry officials and potential partners. In an oral presentation held at 2 pm on the 3rd (local time)...Pavel Printsev will discuss the current status of development of major clinical projects BBT-877 and BBT-207 (non-small cell lung cancer treatment candidates), as well as future expectations. Share key development milestones. In addition, we are preparing a U.S. clinical trial plan (IND) for BBT-301 (a candidate for the treatment of idiopathic pulmonary fibrosis)..."

Clinical • P2 data • Idiopathic Pulmonary Fibrosis • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bridge Bio promotes paid-in capital increase to shareholders worth 26.2 billion won... “Clinical Acceleration” [Google translation] (Nate) - "Bridge Biotherapeutics...is developing 'BBT-877', a new drug candidate for idiopathic pulmonary fibrosis, and 'BBT-207', a next-generation lung cancer drug candidate, being developed through a paid-in capital increase worth 26.2 billion won. Speed ​​up development...A Bridge Bio official said, 'As the clinical trials of BBT-877 and BBT-207, the two leading tasks, are progressing smoothly, we will preemptively secure the expected costs and further increase the speed of progress so that the time it takes for the product to reach the market.'...'Through this financing, we plan to successfully complete the Phase 2 clinical trial to confirm BBT-877 as a global innovative new drug,'...'We plan to actively pursue technology transfer during Phase 2.'"

Financing • Idiopathic Pulmonary Fibrosis • Lung Cancer • Oncology • Pulmonary Disease • Solid Tumor

Bridge Biotherapeutics again advised to continue P2 study for idiopathic pulmonary fibrosis treatment candidate (Korea Biomedical Review) - "Bridge Biotherapeutics...announced positive feedback from the third Independent Data Monitoring Committee (IDMC) meeting to continue the phase 2 clinical trial of BBT-877, a drug candidate for the treatment of idiopathic pulmonary fibrosis (IPF)....To date, the trial has enrolled approximately 75 percent of its target number of 120 patients. The IDMC, composed of IPF experts and statisticians from the U.S. and Europe, convened for the third time to review safety and efficacy data for 75 participants gathered until April 14. This is the third IDMC meeting, the latest one being held in January."

Trial status • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

Bridge Bio confirms possibility of ‘BBT-877 combination treatment’ for epithelial ovarian cancer [Google translation] (HIT News) - "Bridge Biotherapeutics...published non-clinical research results confirming the possibility of combination treatment of the autotaxin inhibitor 'BBT-877 (development code name)' in epithelial ovarian cancer in an international academic journal in the field of oncology....the number of tumor nodules was found to be reduced by more than 50% in the BBT-877 combination treatment group compared to the paclitaxel single treatment group, a standard anticancer chemotherapy agent for ovarian cancer, and the BBT-877 combination treatment for the resistance and metastasis mechanism of paclitaxel. The possibility was confirmed."

Preclinical • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Autotaxin inhibition attenuates the aortic valve calcification by suppressing inflammation-driven fibro-calcific remodeling of valvular interstitial cells. (PubMed, BMC Med) - "ATX inhibition attenuates the development of FCAVD while protecting against fibrosis and calcification in VICs, suggesting the potential of using ATX inhibitors to treat FCAVD."

Journal • Fibrosis • Immunology • Inflammation • CTGF • IL1RN • TGFB1