Celea Therapeutics Secures $180 Million to Launch First Head-to-Head Phase 3 Trial of Deupirfenidone in IPF
核心洞察
Celea Therapeutics (搜索) completed a $180 million financing round with top-tier investors including RA Capital Management (搜索), Leaps by Bayer (搜索), and PureTech Health to advance deupirfenidone.
Proceeds will fund the SURPASS-IPF trial, the first head-to-head Phase 3 study in idiopathic pulmonary fibrosis (搜索), comparing deupirfenidone directly against pirfenidone with initiation planned for early Q3 2026.
Deupirfenidone, a deuterated next-generation antifibrotic, demonstrated potential to stabilize lung function decline over 26 weeks in the Phase 2b ELEVATE IPF trial with a favorable safety profile.
Celea Therapeutics (搜索), a clinical-stage biopharmaceutical company focused on serious respiratory diseases, announced the completion of a $180 million financing round on July 2, 2026. The syndicate includes RA Capital Management (搜索), Leaps by Bayer (搜索), and founder PureTech Health, alongside a large U.S.-based healthcare-focused fund and a leading sovereign wealth fund. The capital will propel the planned early Q3 2026 initiation of SURPASS-IPF, the first head-to-head Phase 3 trial in idiopathic pulmonary fibrosis (搜索) (IPF), evaluating the superiority of deupirfenidone (LYT-100) against pirfenidone.
"People living with IPF continue to face a devastating disease with limited treatment options, and we believe deupirfenidone has the potential to deliver meaningful improvements for patients," said Sven Dethlefs, Ph.D., Chief Executive Officer of Celea. "We are grateful for the support and confidence of this exceptional group of investors, whose commitment enables us to initiate the Phase 3 SURPASS-IPF trial and advance development of deupirfenidone with the speed and focus this community deserves."
Deupirfenidone: A Next-Generation Antifibrotic
Deupirfenidone is an investigational deuterated form of pirfenidone, one of three FDA-approved therapies for IPF. It has received Orphan Drug Designation from both the U.S. Food and Drug Administration and the European Commission. The current treatment landscape for IPF remains constrained: the uptake of and adherence to approved antifibrotics has historically been limited by a tradeoff between modest efficacy and tolerability, and only approximately 25% of people with IPF in the U.S. had ever received treatment as of 2019.
In the global Phase 2b ELEVATE IPF trial, published in The American Journal of Respiratory and Critical Care Medicine (AJRCCM), deupirfenidone demonstrated the potential to stabilize lung function decline over at least 26 weeks as a monotherapy while maintaining a favorable safety and tolerability profile. Initial data from the open-label extension study suggest this effect may be sustained through at least 52 weeks. Beyond IPF, deupirfenidone may also address multiple underserved fibrotic conditions, including progressive fibrosing interstitial lung diseases.
The SURPASS-IPF Trial Design
The planned pivotal Phase 3 SURPASS-IPF trial is a global, randomized, double-blind, head-to-head study directly comparing deupirfenidone 825 mg TID to pirfenidone 801 mg TID in adults with IPF who are not on background therapy. The primary efficacy endpoint is the change from baseline in absolute forced vital capacity at week 52, which will assess the superiority of deupirfenidone compared with pirfenidone.
"We are delighted to support Celea as it enters this important next stage of development," said Laura Stoppel, Ph.D., Partner at RA Capital Management (搜索). "The compelling results generated to date with deupirfenidone and the Company's bold Phase 3 SURPASS-IPF trial represent a differentiated opportunity to meaningfully change the treatment landscape in IPF. Supported by a seasoned team with a demonstrated track record of successfully advancing innovative medicines, Celea is exceptionally well positioned to execute on its strategy of unlocking the full potential of deupirfenidone for patients."
The Unmet Need in IPF
Idiopathic pulmonary fibrosis (搜索) is a rare, progressive, and fatal lung disease characterized by irreversible scarring of lung tissue that leads to a steady decline in lung function. Median survival following diagnosis is estimated to be two to five years, and currently there is no cure. The limited treatment options and poor prognosis underscore the urgency of developing more effective and tolerable therapies for this patient population.