Celea Therapeutics Doses First Patient in Global Phase 3 SURPASS-IPF Trial Evaluating Deupirfenidone for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

SURPASS-IPF is the first industry-sponsored head-to-head Phase 3 trial in IPF and will evaluate the superiority of deupirfenidone 825 mg TID vs. pirfenidone 801 mg TID

Topline data expected in the second half of 2029

Celea Therapeutics, Inc. ("Celea" or the "Company"), a clinical-stage biopharmaceutical company dedicated to advancing transformative treatments for people with serious respiratory diseases, today announced that the first patient has been dosed in the global Phase 3 SURPASS-IPF trial evaluating the superiority of deupirfenidone 825 mg three times daily (TID) vs. pirfenidone 801 mg TID for the treatment of idiopathic pulmonary fibrosis (IPF). The commencement of the potentially registrational Phase 3 trial follows Celea’s recently completed $180 million financing, enabling the Company to rapidly advance development of deupirfenidone as a potential new standard of care for the treatment of IPF.

"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. “We designed SURPASS-IPF as the first industry-sponsored Phase 3 trial in IPF to evaluate superiority over an approved antifibrotic because we believe deupirfenidone has the potential to achieve a level of efficacy once thought attainable only through combination approaches, while maintaining a favorable tolerability profile. This milestone represents an important step toward delivering a truly differentiated treatment option for people living with this devastating disease."