Bridge Biotherapeutics, Boehringer Ingelheim End Agreement to Develop BBT-877

Bridge Biotherapeutics and Boehringer Ingelheim ended a collaboration and license agreement to develop BBT-877, a potential treatment for idiopathic pulmonary fibrosis (IPF) and other fibrotic disorders.

The companies entered into an agreement in July 2019 and, although no details were provided about its termination, the companies report it was a mutual decision. Bridge Biotherapeutics now will regain all rights to BBT-877.

“Bridge Biotherapeutics is committed to further develop BBT-877 to benefit patients with IPF, whom we want to serve,” James Lee, Bridge’s CEO, said in a press release.

“After receiving and reviewing data and dossiers, we will closely work with regulatory authorities to clarify future development plan and necessary studies to initiate human trials in the future,” Lee said.

The oral medication works by blocking the action of autotaxin (ATX), an enzyme that plays a role in producing lysophosphatidic acid (LPA), which is a fatty molecule involved in fibrosis of the lungs, kidneys and liver.

ATX has been found at increased levels in the lungs of people with IPF. By inhibiting ATX, it is hoped that BBT-877 can slow the disorder’s progression.

The therapy was found to be safe and well-tolerated, and to reduce the levels of LPA among healthy volunteers, in a Phase 1 clinical trial (NCT03830125).

LPA levels fell at least 80% for 24 hours with 400 mg or more of BBT-877 in a single-ascending dose arm of the trial. In a second multiple-ascending dose component, both 100 mg twice daily and 200 mg twice daily reduced LPA levels by up to 90% at a steady state.

The U.S. Food and Drug Administration (FDA) awarded BBT-877 orphan drug designation in early 2019. The designation provides Bridge Biotherapeutics with certain incentives to further develop the potential therapy.

The FDA based its decision on data from a pre-clinical study showing that BBT-877 reduced lung fibrosis, weight loss, and collagen buildup in a mouse model of the disorder.

A Phase 2 trial had been planned to begin in July of this year, but an earlier announcement by Boehringer Ingelheim that the therapy needed additional testing regarding some toxicity concerns complicated this start date.

BBT-877 was discovered by the Korean biotech company LegoChem Biosciences, which licensed exclusive worldwide rights to Bridge Biotherapeutics.