deupirfenidone (LYT-100) / PureTech, Celea Therapeutics - LARVOL DELTA

A phase 1 two-way drug interaction study of deupirfenidone (DPF) and nintedanib (ERS 2026) - "Deupirfenidone was reasonably well-tolerated when dosed alone or co-administered with nintedanib. These data suggest clinically relevant drug-drug interactions with DPF and nintedanib co-administration are unlikely."

P1 data • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Design of SURPASS-IPF: A personalized approach to a phase 3 trial of deupirfenidone compared to pirfenidone in idiopathic pulmonary fibrosis (ERS 2026) - P2 | "SURPASS-IPF is the first phase 3 head-to-head study comparing an investigational drug to an approved antifibrotic in patients with IPF. In addition to standard measures, safety and efficacy will also be evaluated with regard to impact on personal experiences."

P3 data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

SURPASS-IPF, A PHASE 3 STUDY COMPARING DEUPIRFENIDONE TO PIRFENIDONE, USES QUANTITATIVE HRCT TO ENSURE A REPRESENTATIVE DISTRIBUTION OF LUNG FIBROSIS SEVERITY VS PROFILE (CHEST 2026) - No abstract available

P3 data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Respiratory Diseases

SURPASS-IPF: Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P3 | N=1100 | Recruiting | Sponsor: PureTech | Trial completion date: Jul 2029 ➔ Dec 2029 | Trial primary completion date: Jun 2029 ➔ Nov 2029

Head-to-Head • Trial completion date • Trial primary completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Celea Therapeutics Will Present Phase 3 Trial Design for Idiopathic Pulmonary Fibrosis and Key Insights from a Deupirfenidone Drug-Drug Interaction Study at the Upcoming European Respiratory Society (ERS) Congress (Businesswire) - "The presentations will detail the design and rationale for SURPASS-IPF, Celea’s global Phase 3 trial evaluating the potential superiority of deupirfenidone 825 mg three times daily (TID) versus pirfenidone 801 mg TID. SURPASS-IPF will assess not only several clinical endpoints but also the potential impact on patients’ lives via patient-reported outcomes. For the first time, Celea will also share results from a Phase 1 drug-drug interaction study evaluating co-administration of deupirfenidone and nintedanib."

Clinical protocol • P1 data • Idiopathic Pulmonary Fibrosis

SURPASS-IPF: Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P3 | N=1100 | Recruiting | Sponsor: PureTech | Not yet recruiting ➔ Recruiting

Enrollment open • Head-to-Head • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Celea Therapeutics Doses First Patient in Global Phase 3 SURPASS-IPF Trial Evaluating Deupirfenidone for the Treatment of Idiopathic Pulmonary Fibrosis (IPF) (Yahoo Finance) - "The pivotal Phase 3 SURPASS-IPF trial is a global, randomized, double-blind, head-to-head trial comparing deupirfenidone 825 mg TID to pirfenidone 801 mg TID over 52 weeks in adults living with IPF who are not receiving background antifibrotic therapy....The trial is expected to enroll approximately 1,100 people living with IPF across more than 30 countries....Topline results from the Phase 3 SURPASS-IPF trial are expected in the second half of 2029. Based on feedback from the FDA, results from this single Phase 3 trial, supported by the totality of data from the overall deupirfenidone development program, could complete the data package required to support potential registration of deupirfenidone in the U.S."

P3 data: top line • Trial status • Idiopathic Pulmonary Fibrosis

PureTech Founded Entity Celea Therapeutics Completes $180 Million Financing to Advance Deupirfenidone as a Potential New Standard of Care to Treat Idiopathic Pulmonary Fibrosis (IPF) (Businesswire) - "Proceeds from the financing will support the planned early Q3 2026 initiation of the Phase 3 SURPASS-IPF trial of deupirfenidone (LYT-100), an investigational next-generation antifibrotic with the potential to serve as a new standard of care for people living with idiopathic pulmonary fibrosis (IPF)....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."

Financing • Trial initiation date • Idiopathic Pulmonary Fibrosis • Immunology

The company announced presentations showcasing its deupirfenidone (LYT-100) program at the upcoming American Thoracic Society (ATS) International Conference, taking place in Orlando, Florida, from May 15-20, 2026 (Yahoo Finance) - "Presentations to highlight differentiated approach to advancing deupirfenidone, reinforcing its potential to serve as a new standard of care within the evolving idiopathic pulmonary fibrosis treatment landscape."

P3 data • Idiopathic Pulmonary Fibrosis

Deupirfenidone Compared with Pirfenidone and Placebo in Idiopathic Pulmonary Fibrosis (ELEVATE-IPF): a Phase 2b Randomized Placebo-Controlled Trial. (PubMed, Am J Respir Crit Care Med) - P2 | "In patients with IPF, treatment with deupirfenidone slowed lung disease progression over 26 weeks."

Journal • P2b data • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

A phase 1 pharmacokinetics study of deupirfenidone (LYT-100) in healthy older adults. (PubMed, ERJ Open Res) - "Results suggest evaluating a dose for deupirfenidone in healthy older adults of between 550 mg three times daily and 825 mg three times daily. Both doses are being evaluated in a 26-week, phase 2b study in patients with IPF."

Journal • P1 data • PK/PD data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

PK of Deupirfenidone Versus Pirfenidone in Older Healthy Subjects (clinicaltrials.gov) - P1 | N=116 | Completed | Sponsor: PureTech

New P1 trial

Deep Learning-based HRCT Assessment of Baseline Disease Severity in the Deupirfenidone Elevate IPF Trial: Comparison With a Well-Characterised IPF Population (ATS 2026) - No abstract available

Clinical • Idiopathic Pulmonary Fibrosis

SURPASS-IPF: Study Design of a Phase 3, Head-to-head Trial of Deupirfenidone Compared to Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ATS 2026) - No abstract available

Clinical • Head-to-Head • P3 data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

PureTech Announces Orphan Drug Designations Granted by the U.S. Food and Drug Administration and European Commission for Deupirfenidone (LYT-100) in Idiopathic Pulmonary Fibrosis (Businesswire) - "Results from the global Phase 2b randomized, double-blind, active- and placebo-controlled, dose-ranging ELEVATE IPF trial underscored the differentiated profile of deupirfenidone....PureTech’s Founded Entity, Celea Therapeutics, intends to finalize financing in the first half of 2026 to support the initiation of the Phase 3 SURPASS-IPF trial in the first half of 2026. SURPASS-IPF will compare deupirfenidone 825 mg TID to pirfenidone 801 mg TID in a head-to-head study powered to test for superiority."

Financing • Orphan drug • Trial initiation date • Idiopathic Pulmonary Fibrosis

Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) and Nintedanib (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: PureTech | Not yet recruiting ➔ Completed

Trial completion

SURPASS-IPF: Phase 3 Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P3 | N=1100 | Not yet recruiting | Sponsor: PureTech

Head-to-Head • New P3 trial • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

PureTech Announces Successful End-of-Phase 2 Meeting with FDA for Deupirfenidone (LYT-100) in Idiopathic Pulmonary Fibrosis (Businesswire) - "The pivotal Phase 3 SURPASS-IPF trial will be a global, randomized, double-blind, head-to-head trial comparing deupirfenidone 825 mg three times-a-day (TID) to pirfenidone 801 mg TID in adults with IPF....PureTech believes that the results from this single Phase 3 trial...could complete the data package required to support potential registration of deupirfenidone via a streamlined 505(b)(2) pathway. The EOP2 meeting was supported by results from the global Phase 2b randomized, double-blind, active- and placebo-controlled, dose-ranging ELEVATE IPF trial....Celea Therapeutics, expects to finalize financing in early 2026 to support the initiation of the Phase 3 SURPASS-IPF trial in the first half of 2026."

FDA event • New P3 trial • Idiopathic Pulmonary Fibrosis

PureTech Presents New Phase 2b Analyses Demonstrating Consistent Safety and Efficacy of Deupirfenidone in Older Patients with Idiopathic Pulmonary Fibrosis (IPF), a Historically Undertreated Group (Businesswire) - "Treatment emergent adverse events, including gastrointestinal events, were similar for both age groups, indicating that older patients tolerated deupirfenidone comparably to younger patients. For example, the rates of nausea in patients aged ≥75 years vs. <75 years were 18.2% vs. 21.4% for deupirfenidone 825 mg TID; 14.3% vs. 18.2% for deupirfenidone 550 mg TID; 25.9% vs. 27.8% for pirfenidone 801 mg TID; and 9.5% vs. 6.8% for placebo."

P2b data • Idiopathic Pulmonary Fibrosis

ELEVATE IPF PHASE 2B RESULTS (DEUPIRFENIDONE VS. PLACEBO AND PIRFENIDONE) IN PATIENTS AGED ≥75 COMPARED WITH <75 YEARS (CHEST 2025) - "Patients aged $75 years on deupirfenidone arms had similar safety/tolerability compared with younger patients with favorable efficacy. CLINICAL IMPLICATIONS: Data support continued clinical development of deupirfenidone in older patients."

Clinical • Late-breaking abstract • P2b data • Idiopathic Pulmonary Fibrosis • Immunology

PureTech Presents New Data from Phase 2b Open-Label Extension Study of Deupirfenidone (LYT-100), Further Supporting Strong and Durable Efficacy and Potential to Serve as New Standard of Care in IPF (Yahoo Finance) - "Those who switched from placebo to deupirfenidone 825 mg TID (n=17) had a mean change in FVC of +20.0 mL (placebo switch cohort), while those who switched from pirfenidone to deupirfenidone 825 mg TID (n=16) had a mean change in FVC of -23.1 mL (pirfenidone switch cohort)....Regulatory engagement underway; update on Phase 3 trial design expected in Q4 2025."

New P3 trial • P2b data • Idiopathic Pulmonary Fibrosis

Late Breaking Abstract - ELEVATE IPF phase 2b open-label extension demonstrates durable efficacy of deupirfenidone (ERS 2025) - No abstract available

Clinical • Late-breaking abstract • P2b data • Idiopathic Pulmonary Fibrosis

PureTech spins out new lung disease unit to advance IPF candidate (Firstwordpharma Press Release) - "A meeting with the FDA to discuss the mid-stage results along with the proposed Phase III design is expected by the end of the third quarter."

Commercial • FDA event • New P3 trial • Idiopathic Pulmonary Fibrosis

PureTech Showcases Differentiated Development Strategy, Including New Patient Preference Insights, and Spotlights Phase 2b Data Positioning Deupirfenidone as a Potential New Standard of Care in IPF (Businesswire) - "The Company highlighted the strength of its Phase 2b ELEVATE IPF trial data supporting the advancement of deupirfenidone (LYT-100) into Phase 3 by its newest Founded Entity, Celea Therapeutics ('Celea')....PureTech intends to discuss a Phase 3 trial design with the U.S. Food and Drug Administration that recapitulates key aspects of ELEVATE IPF, thereby minimizing technical risk from protocol changes."

Clinical protocol • Idiopathic Pulmonary Fibrosis

Deupirfenidone (LYT-100) in post-acute sequelae of SARS-CoV-2 with respiratory complications. (PubMed, ERJ Open Res) - P2 | "Most patients with PASC and respiratory complications showed significant improvement over 91 days irrespective of treatment assignment. Deupirfenidone was well tolerated, with low rates of TEAEs, which supports further investigation in patients with idiopathic pulmonary fibrosis."

Journal • Dyspepsia • Idiopathic Pulmonary Fibrosis • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases