Phase 2b Clinical Study Begins to Evaluate Bexotegrast for IPF


The U.S. FDA has approved two treatments for people living with idiopathic pulmonary fibrosis (IPF). These therapies—Esbriet (pirfenidone) and Ofev (nintedanib)—both work to reduce fibrosis, or scarring, in the lungs. However, neither therapy can stop IPF from progressing. Additional pharmacological solutions are needed to contribute to the best patient outcomes. 

According to a news release from clinical-stage biotechnology company Pliant Therapeutics, Inc. (“Pliant”), the company is working towards a solution through the development of bexotegrast. Pliant shared that the company is now initiating the Phase 2b BEACON-IPF study, a 52-week dose-ranging, double-blind study. 270 participants will enroll. Participants will receive either 160mg bexotegrast, 320mg bexotegrast, or a placebo. In addition to safety, efficacy, and tolerability, researchers will be exploring how well bexotegrast reduces hospitalization needs and improves forced vital capacity (FVC), a sign of lung function. 

A Quick Overview of Bexotegrast

The Pulmonary Fibrosis Foundation explains that bexotegrast is:

an oral once daily antifibrotic [that] inhibits integrins αVβ1 and αVβ6, which in turn blocks activation of TGF-β, a central mediator of fibrosis. This upstream inhibition of TGF-β activation may prevent the formation of fibrotic tissue within the lung.

Preclinical studies suggest that bexotegrast is safe and well-tolerated in people living with IPF. Outside of IPF, Pliant is also exploring bexotegrast for primary sclerosing cholangitis. Bexotegrast has received Orphan Drug designation for both indications in the United States and European Union. 

The Facts: Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic pulmonary fibrosis is a serious, chronic condition which causes scarring in the lungs. As the lungs become scarred and stiff, breathing becomes increasingly difficult. Additionally, oxygen does not flow as well from the lungs to the blood. If you smoke, or have a family history of IPF, you are at a higher risk of developing this condition. 

Symptoms associated with this disease may include:

  • Chest pain or tightness
  • A dry, hacking cough
  • Shortness of breath and/or difficulty breathing 
  • Fatigue and general weakness 
  • Appetite loss
  • Swollen legs
  • Clubbed fingernails and toenails
  • Unintended weight loss
  • Gastroesophageal reflux
  • Joint and muscle aches
  • Pneumonia (complication)
  • Blood clots in the lungs (complication)
Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

Follow us