PBI-4050 Slows Pulmonary Fibrosis Patients’ Lung-function Decline, Phase 2 Trial Suggests

PBI-4050 Slows Pulmonary Fibrosis Patients’ Lung-function Decline, Phase 2 Trial Suggests

Prometic’s PBI-4050 leveled off idiopathic pulmonary fibrosis patients’ decline in lung function, indicating it is a promising treatment for the disease, according to a Phase 2 clinical trial.

The leveling occurred when PBI-4050 was used by itself and when it was used in one of two combination therapies. IPF progressed when PBI-4050 was used in the other combo, however.

Prometic presented the trial results at the American Thoracic Society International Conference in Washington, which ended today. The presentation was titled “PBI-4050 Is Safe and Well Tolerated and Shows Evidence of Benefit in Idiopathic Pulmonary Fibrosis.”

The trial (NCT02538536) examined changes in a measure of lung function known as forced vital capacity in 40 IPF patients who received one of three therapies for 12 weeks. Nine received PBI-4050 alone, 16 a combination of PBI-4050 and Ofev (nintedanib), and 15 a combination of PBI-4050 and Esbriet (pirfenidone).

Forced vital capacity, or FVC, refers to the amount of air a person can force from their lungs after taking a breath that filled their lungs to capacity.

The FVC scores of the patients who took PBI-4050 by itself or a combination of PBI-4050 and Ofev changed very little between the start of treatment and the end. Since IPF is a progressive disease, the minimal change in FVC scores suggested PBI-4050 had slowed or stopped the disease’s progression — a sign it had been effective.

In contrast, the FVC scores of patients receiving the combination of PBI-4050 and Esbriet dropped significantly, indicating they had experienced a loss in lung function.

The research team speculated that PBI-4050 and Esbriet interacted in a way that reduced both’s effectiveness.

Another presentation that Prometic made at the conference also suggested that PBI-4050 was effective against IPF. It focused on the therapy’s impact on disease biomarkers.

PBI-4050 generated much larger reductions in biomarkers of harmful IPF processes, including inflammation, extracellular matrix accumulation and pulmonary vascular remodeling, than Ofev and Esbriet.

The presentation was titled “PBI-4050 Reduces Expression of Fibrosis Biomarkers in the BioMAP SAEMyoF Primary Human Small Airway Epithelial Cells and Lung Myofibroblasts System.”

Prometic is now planning two placebo-controlled Phase 2/3 clinical trials in the second half of 2017. One will test PBI-4050 in combination with Ofev. Another will evaluate PBI-4050 alone in patients unable to tolerate Ofev or Esbriet.

“PBI-4050 presented a highly compelling safety and tolerability profile throughout all clinical trials,” Dr. Joseph Parker, senior director of clinical development at Prometic, said in a press release. “Because PBI-4050 was well-tolerated and appeared to demonstrate a dose response relationship in the Phase 2 study, the planned pivotal Phase 2/3 trial will include three arms – two dose levels of PBI-4050 and placebo.”

 

 

Janet Stewart is a life sciences writer and editor, who completed both PhD course work and oral examinations in the Department of Microbiology and Immunology at McGill University, and holds an M.Sc. in Virology and Immunology.
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Janet Stewart is a life sciences writer and editor, who completed both PhD course work and oral examinations in the Department of Microbiology and Immunology at McGill University, and holds an M.Sc. in Virology and Immunology.
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