Bridge Biotherapeutics Reaffirms BBT-877 at JPM Healthcare Conference

Bridge Biotherapeutics, which secured a landmark $1 billion deal in 2019, faced a setback in October 2020 when its partnership with Boehringer Ingelheim for idiopathic pulmonary fibrosis (IPF) drug candidate BBT-877 was terminated. Four years later, the company is regaining momentum, earning a main stage presentation at the JPM Healthcare Conference, a sign of renewed confidence in the drug’s potential.

Currently in Phase 2 global trials, Bridge Biotherapeutics plans to disclose top-line data soon. CEO Jung-kyu Lee, in a recent interview with Hit News, confirmed ongoing discussions regarding a global licensing agreement and emphasized the company’s strengthened belief in BBT-877’s efficacy. Since regaining full rights, the company has independently refined its clinical strategy, focusing on long-term efficacy through extended dosing regimens.

BBT-877 selectively inhibits autotaxin, a plasma protein linked to inflammation and fibrosis. CEO Lee highlighted three key factors behind the drug’s development: the novelty of autotaxin inhibition, minimal competition in the field, and the high unmet medical need in IPF, a severe and rare disease.

Current IPF treatments, Ofev (nintedanib) and Esbriet (pirfenidone), slow disease progression but do not offer a cure and often cause significant side effects. Unlike these therapies, BBT-877 is designed not only to suppress myofibroblast formation but also to clear accumulated myofibroblasts, potentially modifying the disease course.

By inhibiting autotaxin, BBT-877 reduces lysophosphatidic acid (LPA) levels, which play a critical role in fibrosis progression. This dual mechanism positions BBT-877 as a promising candidate capable of both halting disease advancement and potentially reversing fibrosis.

“If our clinical trials validate this advantage, BBT-877 could establish itself as a highly competitive and transformative therapy in the IPF market,” Lee stated.

A key advantage of BBT-877 is its biomarker-based validation approach. Lee explained, “Biomarkers provide a measurable indicator of a drug’s action and effectiveness.” BBT-877’s efficacy can be assessed by tracking LPA levels in the bloodstream, offering real-time insights into treatment response.

Unlike existing IPF drugs evaluated over 12-week trials, BBT-877’s 24-week study provides a more comprehensive analysis of long-term effects. Given that IPF treatment typically requires extended therapy, these findings will serve as a critical benchmark for real-world therapeutic potential.

Bridge Biotherapeutics has integrated Brainomix’s AI-based e-ILD technology into its Phase 2 trials to improve clinical precision. This tool analyzes high-resolution computed tomography (HRCT) images, enabling a systematic and quantitative evaluation of disease progression.

Traditional IPF trials rely on forced vital capacity (FVC) measurements, which can be inconsistent due to patient variability. AI-driven imaging analysis provides a more objective assessment of lung fibrosis, complementing FVC measurements for enhanced accuracy.

Lee noted, “By incorporating AI-based analysis, we ensure a more reliable evaluation of BBT-877’s efficacy.” While detailed efficacy data remains blinded, he expressed confidence that positive results will drive strong market interest and potential out-licensing agreements for Phase 3 trials.

Despite the challenges following Boehringer Ingelheim’s return of BBT-877, Bridge Biotherapeutics leveraged the experience to refine its clinical expertise. “Collaborating with a global leader in IPF provided invaluable insights, reinforcing our confidence in BBT-877,” Lee stated. Independent research reaffirmed the promise of autotaxin inhibition, guiding strategic refinements.

The company operates the Boston Discovery Center (BDC), a global R&D hub, and collaborates with over 50 clinical sites across five countries for its Phase 2 trials. Post-licensing, Bridge Biotherapeutics plans to expand BDC operations and establish a fully integrated drug discovery platform.

In parallel, the company is advancing BBT-301, an IPF candidate that increases cAMP levels. Developed through drug repositioning, BBT-301 repurposes an existing CNS drug for IPF, accelerating its clinical pathway.

Following a Pre-IND meeting, the company secured a Phase 1 trial waiver and plans to submit a Phase 2 IND application to the FDA this year.

Lee emphasized, “Our decade-long expertise in clinical trial design and execution with BBT-877 will serve as a foundation for advancing next-generation fibrosis treatments and strengthening global competitiveness.”