1st patient dosed in Phase 2a trial of BBT-877 for IPF
Trial is recruiting at 20 sites across the U.S., Australia, Israel, South Korea
The first participant has been dosed in a clinical trial testing the experimental anti-fibrotic therapy BBT-877 in people with idiopathic pulmonary fibrosis (IPF).
The milestone was announced by BBT-877’s developer Bridge Biotherapeutics, which initiated the trial late last year.
“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,” James Lee, founder and CEO of Bridge, said in a company press release. “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.”
Study seeking to enroll 120 adults with IPF at sites globally
The ongoing Phase 2a study (NCT05483907) aims to recruit about 120 adults with IPF, 40 and older. The study is open to patients whether or not they have been treated with IPF-specific therapies, such as approved therapies Esbriet (pirfenidone) and Ofev (nintedanib). To be eligible, participants must meet certain physical and lung function requirements. Current smokers are not eligible to participate.
Trial participants will be randomly assigned to take 200 mg of BBT-877 or a placebo, twice daily, for 24 weeks, or about six months. The study’s main goal is to evaluate the effect of treatment on forced vital capacity, a standard measure of lung function that assesses how much air a person can forcibly exhale after a deep breath. Top-line data are expected later this year, according to Bridge.
The study is currently recruiting participants at 20 locations across the U.S., Australia, Israel, and South Korea. The trial is expected to include a total of about 50 sites across North America, Europe, and the Asia Pacific region.
BBT-877 is an oral therapy designed to lower the levels of lysophosphatidic acid (LPA), a fatty molecule that promotes scarring, or fibrosis, in IPF and other disorders. The experimental medication specifically blocks the activity of autotaxin, an enzyme that helps make LPA and is thought to be overactive in IPF. BBT-877 has been granted orphan drug designation in the U.S., which is given to incentivize and support the development of treatments for rare disorders.
Early preclinical data have shown that treatment with BBT-877 led to a substantial reduction in fibrosis in an IPF mouse model, and data from a Phase 1 study (NCT03830125) involving healthy volunteers suggested the experimental therapy was safe and able to reduce LPA levels as intended.