Pliant launches Phase 2b trial of oral bexotegrast in IPF
Trial follows positive data from the INTEGRIS-IPF study that tested 119 patients
Called BEACON-IPF, it intends to recruit about 270 patients at clinical sites around the globe. Details on site locations and when recruitment will start haven’t been disclosed. The participants will be randomly assigned to either a daily dose of 160 or 320 mg of bexotegrast or a placebo for 52 weeks (about a year).
The study’s primary goal is to assess changes in absolute forced vital capacity (FVC), a measure of lung function that assesses the total amount of air a person can exhale after a deep breath.
Secondary measures include the time to disease progression — defined as a decline in FVC percent predicted of 10% or more, a respiratory-related hospitalization, or death — and changes in absolute FVC from the study’s start (baseline). Changes in patient-reported symptoms and well-being, along with safety and tolerability will also be assessed.
“IPF remains an area of great unmet need. With the start of BEACON-IPF, we are achieving an important company milestone and taking a step forward to potentially bringing this novel drug candidate to patients,” Éric Lefebvre, MD, chief medical officer at Pliant Therapeutics, said in a company press release.
What is bexotegrast and how does it work?
Bexotegrast is a small molecule that blocks two proteins — alpha v beta 6 and alpha v beta 1 — that are found at high levels in the lungs of people with IPF. Both are believed to contribute to the tissue scarring (fibrosis) that marks the condition, so blocking them is expected to reduce or halt fibrosis.
The trial comes on the heels of positive data from the INTEGRIS-IPF trial (NCT04396756), a Phase 2a study that tested bexotegrast doses of 40-320 mg versus a placebo in 119 people with IPF. Treatment was given daily for 48 weeks and about 80% of patients continued to receive their standard IPF therapies.
At three months post-treatment, the patients treated with the 320 mg dose were already showing improvements in FVC and slower changes in lung fibrosis over the placebo group. Disease-associated biomarkers and cough severity were also reduced.
Follow-up data collected at six months continued to support the therapeutic benefits of the high dose, which was also found to be well tolerated for up to nine months.
“BEACON-IPF follows the positive results from our Phase 2a INTEGRIS-IPF trial demonstrating bexotegrast was well tolerated and demonstrated encouraging preliminary patient benefits for those both on and off current background therapies,” Lefebvre said. “We look forward to advancing this trial to further our understanding of bexotegrast as a potential therapy in the treatment of IPF.”