Use of a recombinant human protein in stage 2 clinical trials has offered promising results and new hope for those suffering from idiopathic pulmonary fibrosis, or IPF.

Results of the randomized trial were published yesterday in JAMA, and the lead author, Dr. Ganesh Raghu, presented findings yesterday at the American Thoracic Society meeting in San Diego. UW Medical Center was one of the lead sites in the study.

The study was a randomized trial, which included 117 patients with IPF. One group received IV recombinant human pentraxin-2 and the other received a placebo. Those that received the drug every 4 weeks, for 24 weeks, saw a slower decline in disease progression as measured in lung function tests and stabilized their walk distances covered over a 6-minute time, the paper states.

“Stabilization in patients’ ability to function as assessed by walk distances has not been shown before,” said Raghu, UW Medicine’s Director, Center for Interstitial Lung Disease in Seattle. Patients were also able to tolerate the drug, the trial showed, and did not get sick from the treatment. Raghu said the slower rate of disease progression, stabilization in their walk capacities, and the tolerance of the treatment regimen by research subjects is significant.

“From the patients’ perspective, they care about their quality of life and their day-to-day activities,” he said.

The prognosis of IPF, a progressive fibrotic lung disease, is poor. The 5-year survival rate for those with the disease—usually older men—is 20% to 40%.

“The quality of life in many patients is poor, you are short of breath and limited in activities,” Raghu said. “They cannot walk as much as they did at the time of onset of the disease, and every 3 to 4 months, they sense their levels of physical activity are less over time and their breathing deteriorates.”

No cure has been found, and physicians are still unclear on what causes the condition. But, offering a drug that stabilizes the deterioration, and allows the patients a better quality of life, is significant, Raghu said. The drug appears to modulate the inflammation and scarring process (‘fibrotic process’) at a cellular level in the lung.

Currently, the only treatment drugs approved for the disease are pirfenidone and nintedanib, but neither treatment halts the disease progression. The mean age of the patients was 68.6 years, and 81% of the patients were male. Most of the patients had been diagnosed about 4 years prior to the trial. At the end of the 6-month trial for the patients taking the drug, the rate of lung function decline slowed down.

Stage 3 trials of the drug will likely be announced later this year, Raghu said.

The clinicaltrials.gov number is NCT0255073.