Clinical trials are incredibly meaningful in advancing research, understanding, and potential treatments for many conditions. Unfortunately, these trials are not always successful, meaning that the evaluated drugs cannot be considered for patient use. The Phase 3 ZEPHYRUS-1 trial fits within this category. Within this trial, biopharmaceutical company FibroGen, Inc. was assessing pamrevlumab for idiopathic pulmonary fibrosis (IPF). Pamrevlumab is a first-in-class antibody designed to inhibit connective tissue growth factor (CTGF) activity; CTGF can play a role in fibrosis (scarring).
According to a news release discussing the matter, 356 people were involved in the ZEPHYRUS-1 study. Researchers sought to understand how pamrevlumab improved forced vital capacity (FVC). FVC is a measure of lung function; it refers to how much air you can forcibly exhale after taking the deepest breath you can. Low FVC suggests breathing obstructions or difficulties.
After a 48-week period, researchers found that people taking pamrevlumab did not have a strong enough improvement in FVC when compared to a placebo. More so, pamrevlumab failed to successfully slow disease progression to a statistically meaningful point. Although the treatment was both safe and well-tolerated, the efficacy data does not support moving forward. The ZEPHYRUS-2 study, which followed ZEPHYRUS-1, has now been discontinued.
While the trial for IPF is discontinued, FibroGen plans to continue studies exploring pamrevlumab for Duchenne muscular dystrophy (DMD) and locally advanced unresectable pancreatic cancer. More data from these studies should be available later this year or in early 2024.
Learn More: Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic pulmonary fibrosis is just what its name suggests: the formation of thick, fibrous scar tissue in the lungs without a known cause. As lung tissue hardens, it makes it more difficult to breathe. There is no cure for IPF. Treatments like Ofev and Esbriet are designed to slow fibrosis. Still, IPF comes with a prognosis of just 2-5 years following diagnosis. More effective treatment options are needed as soon as possible to help this community.
Symptoms relating to IPF may include shortness of breath, clubbed fingers or toes, gastroesophageal reflux, weight loss, appetite loss, a hacking cough, or blood clots in the lungs. This condition may also cause complications such as lung cancer or pneumonia.
