Boston — Celea Therapeutics has dosed the first patient in a global phase 3 trial evaluating deupirfenidone as a potential treatment for idiopathic pulmonary fibrosis.
The SURPASS-IPF study will compare deupirfenidone 825 mg three times daily with the approved antifibrotic pirfenidone 801 mg three times daily. Celea said it is the first industry-sponsored, head-to-head phase 3 trial in IPF designed to test superiority over an approved treatment.
The randomized, double-blind study is expected to enroll about 1,100 adults in more than 30 countries. Participants will receive one of the two active treatments for 52 weeks, with no placebo arm.
The trial’s primary endpoint is the change from baseline in absolute forced vital capacity, a measure of lung function. Researchers will also evaluate the safety and tolerability of deupirfenidone.
“The speed with which we have progressed from completing our financing to dosing the first patient in SURPASS-IPF reflects the extensive preparation that preceded this milestone, the strength of our organization, and our unwavering focus on execution,” said Sven Dethlefs, PhD., chief executive officer of Celea.
Celea recently completed a $180 million financing to support the continued development of deupirfenidone.
SURPASS-IPF follows the phase 2b ELEVATE-IPF trial and its open-label extension, which the company said showed reduced lung-function decline and a favorable safety and tolerability profile.
“I’m proud that our site was able to dose the first patient in the SURPASS-IPF trial,” said Rafael Lupercio, a pulmonologist at Shasta Critical Care Specialists in Redding, California, and an investigator in the study. “When discussing clinical trial participation with people living with IPF, study design matters. What stands out to me about SURPASS-IPF is that it directly compares deupirfenidone to an approved antifibrotic.”
PureTech Health, which founded Celea, said the start of the study marked an important development milestone for both companies.
Topline results from SURPASS-IPF are expected in the second half of 2029. Celea said feedback from the FDA indicates that results from the trial, together with data from the broader development program, could support a potential U.S. registration application.
