Boehringer Ingelheim has agreed to pay Bridge Biotherapeutics up to €1.1 billion ($1.2 billion) under a collaboration to develop the South Korean biopharma’s BBT-877 for idiopathic pulmonary fibrosis and other fibrosing interstitial lung diseases.

BBT-877 is designed to inhibit autotaxin, an enzyme mediating a key pro-fibrotic event in multiple cell types. The drug has shown a promising safety and efficacy profile in preclinical models for fibrosing interstitial lung diseases and potential for combination with the current standard of care, according to Bridge Biotherapeutics.

BBT-877 is now in a Phase I clinical trial (NCT03830125) designed to assess the safety and tolerability of single and multiple ascending oral doses in healthy adults. At the American Thoracic Society International Conference (ATS 2019), held in Dallas May 17-22, Bridge Biotherapeutics presented positive interim safety and tolerability data for BBT-877, stating that the drug showed only mild adverse events (AEs) and no serious AEs.

The Phase I trial is expected to be finalized by August, Bridge Biotherapeutics said in May. Over the next 12 months, the company expects to begin a multinational Phase II study to be conducted in the United States, Canada, Australia, and multiple countries in Europe and Asia.

BBT-877 is among several pipeline candidates whose development Bridge Biotherapeutics said it would fund through proceeds of KRW 31 billion ($26.4 million) Series C financing closed in April. The financing was led by UTC Investment and Shinhan Investment, with participation by The Korea Development Bank, UNO Investment, and Daewoong.

Bridge Biotherapeutics has raised more than KRW 60 billion ($51 million) in total financing.

“This new collaboration complements our growing pipeline in fibrosing interstitial lung diseases and is a sign of our determination to bring the next generation of treatment options to these patients,” Michel Pairet, member of Boehringer Ingelheim’s board of managing directors with responsibility for the company’s innovation unit, said Thursday in a statement.

“A Transformational Event”

Added B. Christopher Kim, PhD, a board member of Bridge Biotherapeutics and managing partner with investment firm Novatio Ventures: “This is a transformational event for Bridge Biotherapeutics.”

“It is a testament to the company’s excellence in the development of novel therapeutics for disease areas with high unmet medical need,” Kim stated.

Boehringer Ingelheim agreed to pay Bridge Biotherapeutics upfront and “near-term” payments of €45 million ($50.5 million), potentially more than €1.1 billion ($1.2 billion) tied to achieving development, regulatory, and commercial milestones; and tiered up-to-double-digit royalties.

Both companies said they will initially focus on developing BBT-877 for IPF—one of several conditions within respiratory disease, a key therapeutic focus area for Boehringer Ingelheim stretching back to 1921.

Boehringer Ingelheim markets the blockbuster IPF drug OFEV® (nintedanib), an antifibrotic treatment shown to slow disease progression by reducing lung function decline. Last year, OFEV generated €1.1 billion ($1.2 billion) in net sales, up 28.7% over 2017. OFEV is approved as an IPF treatment in more than 70 countries, including the United States, the nations of the European Union, and Japan.

OFEV won FDA approval in October 2014. Since then, Boehringer Ingelheim has devoted more resources to fighting IPF, in part through an R&D collaboration launched in 2016 that could generate up to €170 million (about $191 million) in research funding and milestones for partner Inventiva. In 2017, Inventiva won a €2.5 million ($2.8 million) milestone payment when Boehringer Ingelheim exercised an option for the companies to jointly develop a treatment against an undisclosed target validated by a joint research team.

AI-Based Detection

Also in IPF, Boehringer Ingelheim is developing an artificial intelligence (AI)-based “Auscultation Aid”  designed to detect the disease by comparing a patient’s lung sound recordings with reference data from a cloud-based sound database. The system integrates a stethoscope with a digital interface that is linked via mobile phone to the database.

On April 11, Boehringer Ingelheim signaled its intent to expand in respiratory disease development by announcing its completion of a €105 million ($118 million) expansion of production operations at its sites in Dortmund and Ingelheim, Germany. The expansion was intended to ensure sufficient manufacturing capacity for the next-generation Respimat® inhaler, which was launched in its first European markets earlier this year.

“The expertise of Boehringer Ingelheim will ensure that our novel therapeutic candidate can be developed to potentially address unmet medical needs of IPF patients worldwide,” Bridge Biotherapeutics CEO James Lee stated.

Beyond respiratory diseases, Boehringer Ingelheim’s areas of human therapeutic focus include cardiovascular diseases, central nervous system disorders, immunology, metabolic diseases, and oncology.

In oncology, Boehringer Ingelheim made its latest move on July 15, when the privately held German biopharma expanded its presence in cancer immunotherapy by acquiring Swiss-based AMAL Therapeutics for up to €325 million ($365.5 million).

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