Experimental IPF Therapy Safe and Well-tolerated, Ongoing Phase 1 Study Shows

Bridge Biotherapeutics’ investigational therapeutic candidate BBT-877 for idiopathic pulmonary fibrosis (IPF) was found to be safe and well-tolerated in the single-ascending dose phase of a Phase 1 trial with healthy volunteers, the company announced.

BBT-877 is currently undergoing testing in the multi-ascending dose phase, and Bridge Biotherapeutics is planning a Phase 2 trial.

The results were presented May 19 in a poster titled “BBT-877, a potent Autotaxin Inhibitor in Clinical Development to Treat Idiopathic Pulmonary Fibrosis” at the American Thoracic Society International Conference, May 17-22, in Dallas, Texas.

Autotaxin (ATX) is an enzyme involved in production of a lipid molecule called lysophosphatidic acid that plays a role in inflammation and scarring (fibrosis). Evidence shows that ATX levels are greatly increased in the lungs of IPF patients. By inhibiting ATX, BBT-877 has the potential to reduce inflammation and fibrosis, slowing down IPF progression.

Because of its promising pre-clinical results, BBT-877 recently received orphan drug designation from the U.S. Food and Drug Administration (FDA).

The Phase 1 study (NCT03830125), currently looking for more participants, is testing the safety and tolerability of BBT-877 in healthy volunteers, and is divided into two parts.

The first a single-ascending dose phase, and includes five groups of participants. Each group receives a single increasing dose of BBT-877 based on the safety profile presented by the previous group. This helps monitor the therapy’s pharmacokinetics (meaning the drug’s absorption, distribution, metabolism, and excretion inside the body).

In the second and multi-ascending dose (MAD) phase, three groups will receive multiple increasing doses of the therapy. The MAD phase assesses how the therapy accumulates in the body and its impact.

The trial’s first part enrolled 40 healthy volunteers who were randomized to a placebo (control) or to one of the five doses of BBT-877 delivered as an oral capsule. In three groups, BBT-877 is given once daily, and in two other groups twice a day.

Results from the single-ascending dose phase showed that all tested doses were safe and well-tolerated. Researchers detected only mild adverse events with the treatment, and no serious events.

There were also no clinical findings in safety assessments of the study, such as electrocardiogram, vital signs, laboratory biochemical and blood cells profile, and urinalysis.

The trial’s multi-ascending dose phase is reported to soon finish enrolling another 40 people.

“We remain highly focused on the clinical development of BBT-877,” Gwang-hee Lee, PhD, vice president and head of translational research at Bridge Biotherapeutics, said in a press release.

“BBT-877 has shown potential as a best-in-class ATX inhibitor for treatment of IPF with favorable results in the first in-human clinical study. These findings reinforce our continued collaborations with world-class pulmonologists specializing in IPF,” Lee said.

Given these positive results, Bridge Biotherapeutics is planning a Phase 2 study in the U.S., Canada, Australia, and multiple countries in Europe and Asia.