Bridge Biotherapeutics, which is developing a new drug for idiopathic pulmonary fibrosis (IPF), a rare disease where the lungs harden, will advance to Phase 3 clinical trials through technology transfer. The company noted, "Currently, we are in discussions with five global big pharmaceutical companies, and we will proceed with follow-up clinical trials with one of them starting next year."
Lee Jeong-kyu, representative of Bridge Biotherapeutics, said during the main track presentation at the 43rd JP Morgan Healthcare Conference held at the Westin St. Francis Hotel in San Francisco on Jan. 16 (local time), "The Phase 2 clinical trial is currently in the final stages, and once the top-line results are announced in the second quarter of this year, we will determine the counterpart for technology transfer and plan to submit the Phase 3 Investigational New Drug application to the U.S. Food and Drug Administration in the second half of the year." This marked the first time Bridge Biotherapeutics has attended the JP Morgan conference by official invitation.
Idiopathic pulmonary fibrosis is a rare, intractable disease that causes the lungs to harden, leading to reduced function, and can result in death in severe cases. The survival period after diagnosis is only 3 to 5 years. According to Bridge Biotherapeutics, the number of patients worldwide is approximately 3 million, and the market for idiopathic pulmonary fibrosis treatments is projected to reach around 10 trillion won by 2030.
Existing treatments include Boehringer Ingelheim's "Ofev" and Roche's "Esbriet." However, these treatments primarily delay the decline in lung function rather than directly treating lung fibrosis, extending the survival period by about 3 to 5 years.
In contrast, Bridge Biotherapeutics emphasizes that BBT-877 can effectively treat the decline in lung function. After acquiring BBT-877 from LigaChem Biosciences, the company is currently in the final stage of a Phase 2 clinical trial involving 120 pulmonary fibrosis patients across Asia, Europe, and North America. The representative stated, "BBT-877 is a fundamental treatment that selectively inhibits autotaxin, a protein that causes fibrosis, preventing it from functioning. The Phase 2 trial showed that the representative biomarker for the disease, forced vital capacity (FVC), was higher than that of competing drugs, confirming the potential for lung function recovery."
The company described that the safety issues that had arisen previously have been resolved. Boehringer Ingelheim had previously acquired BBT-877 in 2019 but returned it in 2020 after a year due to the discovery of potential toxicity. The representative noted, "So far, no patients have discontinued clinical trials due to drug side effects," adding, "The frequency of diarrhea, which is commonly cited as a side effect of idiopathic pulmonary fibrosis, was also lower than that of competing drugs."
The Phase 3 trial of BBT-877 is set to be conducted with a total of 1,000 participants divided into three cohorts: high-dose, low-dose, and placebo groups. The company aims to enter the market in the first half of next year through global big pharmaceutical companies.
The representative stated, "We have signed confidentiality agreements (CDA) with more than half of the top 10 big pharmaceutical corporations for joint development and technology transfer," adding, "One of these will carry out the Phase 3 trial for idiopathic pulmonary fibrosis as well as the clinical trial for progressive pulmonary fibrosis (PPF), which has a similar natural progression."