The first patient has been dosed in phase 2a clinical study evaluating the efficacy, safety, and tolerability of BBT-877 in people with idiopathic pulmonary fibrosis (IPF), according to Bridge Biotherapeutics.
The company expects to announce topline data in the second half of 2023.
“The first patient dosing of BBT-877 marks an important milestone in our efforts to develop innovative treatments for patients suffering from idiopathic pulmonary fibrosis. We are dedicated to the advancement of this novel drug candidate, which we believe has the potential to make a meaningful impact in the lives of IPF patients and their families,” said James Lee, founder, and CEO of the company.
The phase 2, multicenter, randomized, double-blind, placebo-controlled study will enroll approximately 120 patients in about 50 sites in North America, Europe, and the Asia Pacific region.
Read more about IPF therapies
The eligible patients may or may not have received the current standard IPF treatment consisting of pirfenidone or nintedanib. According to the study dosing regimen, the participants will self-administer 200 mg of BBT-877 or placebo twice per day.
BBT-877 is an orally administered autotaxin enzyme inhibitor. In phase 1 of the study, the experimental medication demonstrated its ability to inhibit lysophosphatidic acid production by as much as 90%.
Lysophosphatidic acid is known as an inductor of neovascularization, sclerosis, tumorigenesis, and tumor metastasis and is linked to the development of several fibrotic conditions such as IPF.
The National Institutes of Health in the US estimates that more than 30,000 new cases of IPF are diagnosed across the country every year and about 3 million patients are affected by the disease around the globe.
Bridge Biotherapeutics announces first patient dosed in its phase 2a clinical trial of BBT-877, a potent autotaxin inhibitor for the treatment of idiopathic pulmonary fibrosis. News release. Bridge Biotherapeutics, Inc.; April 12, 2023.