deupirfenidone (LYT-100) / Teva, PureTech - LARVOL DELTA

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

Deupirfenidone Compared to Placebo and Pirfenidone in Idiopathic Pulmonary Fibrosis: ELEVATE IPF Phase 2b Trial (ATS 2025) - "Deupirfenidone met both FVC and FVCpp endpoints in the primary Bayesian approach and a dose response between 550 mg and 825 mg was demonstrated. DPF 825 mg also met both endpoints, demonstrated statistical significance by a frequentist approach, and had an FVC decline that approached the level seen with the normal aging process. Deupirfenidone was well tolerated at both doses and safety was consistent with previous studies."

Clinical • Late-breaking abstract • P2b data • Dyspepsia • Fatigue • Idiopathic Pulmonary Fibrosis • Immunology • Pain • Pulmonary Disease • Respiratory Diseases

PureTech’s Deupirfenidone (LYT-100) Demonstrates Strong and Durable Efficacy as a Monotherapy with Favorable Tolerability in Phase 2b ELEVATE IPF Trial (Businesswire) - P2b | N=240 | ELEVATE (NCT05321420) | Sponsor: PureTech | "PureTech Health plc...delivered a late-breaking, oral presentation at the 2025 American Thoracic Society (ATS) International Conference....In the trial, patients treated with deupirfenidone 825 mg three times a day (TID) experienced a slower rate of lung function decline, as measured by Forced Vital Capacity (FVC), at 26 weeks versus those who were treated with placebo (-21.5 mL vs. -112.5 mL, respectively; p=0.02). This statistically significant difference represents a robust treatment effect versus placebo of 80.9% for deupirfenidone 825 mg TID as a monotherapy. This result compares favorably against the rate of decline in FVC observed in the trial among patients treated with pirfenidone 801 mg TID versus placebo (-51.6 mL vs. -112.5 mL, respectively)..."

Late-breaking abstract • P2b data • Idiopathic Pulmonary Fibrosis

PureTech to Present Results from Phase 2b ELEVATE IPF Trial of Deupirfenidone (LYT-100) at the American Thoracic Society International Conference (Businesswire) - P2b | N=240 | ELEVATE (NCT05321420) | Sponsor: PureTech | "PureTech Health plc...today announced that the Company will deliver a late-breaking oral presentation at the upcoming American Thoracic Society (ATS) International Conference...which demonstrated unprecedented efficacy outcomes in patients living with idiopathic pulmonary fibrosis (IPF), including the potential to stabilize lung function decline at 26 weeks while maintaining safety and tolerability....Deupirfenidone demonstrated the potential to stabilize lung function decline over 26 weeks as a monotherapy—something not achieved by marketed or investigational IPF therapies, to our knowledge....PureTech is targeting a meeting with the U.S. Food and Drug Administration by the end of the third quarter of 2025 to discuss the results of the Phase 2b trial and align on a potential registrational pathway, with the goal of initiating a Phase 3 trial by the end of 2025."

FDA event • New P3 trial • P2b data • Idiopathic Pulmonary Fibrosis

PureTech Announces Annual Results for Year Ended December 31, 2024 (Businesswire) - "PureTech continued to progress the development of deupirfenidone as a potential new standard of care for the treatment of IPF, a progressive and fatal lung disease....PureTech will present additional details from the Phase 2b trial at the American Thoracic Society International Conference in May 2025....Vedanta anticipates topline results from its Phase 2b clinical trial of VE202 in ulcerative colitis in 2025."

P2b data • Idiopathic Pulmonary Fibrosis • Ulcerative Colitis

ELEVATE: LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=240 | Active, not recruiting | Sponsor: PureTech | Trial completion date: Aug 2025 ➔ Dec 2025

Trial completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

PureTech’s Deupirfenidone (LYT-100) Slowed Lung Function Decline in People with Idiopathic Pulmonary Fibrosis (IPF) as Measured by Forced Vital Capacity (FVC), Achieving the Primary and Key Secondary Endpoints in the ELEVATE IPF Phase 2b Trial (Businesswire) - P2b | N=240 | ELEVATE (NCT05321420) | Sponsor: PureTech | "PureTech Health plc...today announced positive results from ELEVATE IPF...The rate of FVC decline at week 26 with: deupirfenidone 825 mg TID compared to placebo was statistically significant (-21.5 mL vs. -112.5 mL, respectively; p=0.02)4 and represents a robust treatment effect of 80.9% as a monotherapy; for context, the level of six-month natural decline in lung function as measured by FVC expected in healthy adults over 60 years old is approximately -15.0 mL to -25.0 mL. pirfenidone 801 mg TID showed a treatment effect of 54.1% compared to placebo (-51.6 mL vs. -112.5 mL, respectively), which is consistent with previously reported pirfenidone clinical trial data. The trial also achieved its key secondary endpoint based on a prespecified Bayesian analysis, with a posterior probability of 99.6%."

P2b data • Idiopathic Pulmonary Fibrosis

PureTech’s Deupirfenidone (LYT-100) Slowed Lung Function Decline in People with Idiopathic Pulmonary Fibrosis (IPF) as Measured by Forced Vital Capacity (FVC), Achieving the Primary and Key Secondary Endpoints in the ELEVATE IPF Phase 2b Trial (Yahoo Finance) - P2b | N=NA | ELEVATE (NCT05321420) | Sponsor: | Puretech | "'The ELEVATE IPF trial broke new ground in Phase 2 trial design in IPF; this was the first time that a new therapy (deupirfenidone) has been evaluated alongside one of the two existing standard-of-care treatments (pirfenidone),' said Toby Maher, MD, PhD...'Deupirfenidone 825 mg TID reduced lung function decline to near-physiologic levels over 26 weeks and had an effect size, compared with placebo, that was approximately 50% greater than that seen with pirfenidone. Deupirfenidone has the potential to offer patients a highly effective and tolerable treatment option. These are extremely exciting results from a Phase 2b trial, and I am very enthusiastic about the continued development of deupirfenidone.'"

Media quote • P2b data • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) and Nintedanib (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: PureTech

New P1 trial

BAYESIAN APPROACH FOR ELEVATE IPF: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE EFFICACY, SAFETY, AND DOSE RESPONSE OF DEUPIRFENIDONE (LYT-100) IN IPF (CHEST 2024) - "There is precedent for leveraging Bayesian methodology in IPF studies (i.e., phase 2 programs for BI 1015550 and BMS-986278) to minimize the number of patients exposed to placebo while still generating data sufficient for decision making in drug development...The study will evaluate approximately 240 treatment-naïve adult participants, or those with less than 6 months exposure to nintedanib, at least 40 years of age at approximately 120 study centers globally... The Bayesian dynamic borrowing approach leverages the plethora of placebo data available from prior IPF studies. This approach has the potential to significantly enhance the statistical power of this study while limiting the number of patients required to be treated with placebo. CLINICAL IMPLICATIONS: Bayesian dynamic borrowing allows for historic IPF controls to complement clinical trial data to maximize the number of patients exposed to active treatment arms and minimize the number exposed to placebo."

Clinical • Idiopathic Pulmonary Fibrosis • Immunology • Oncology • Rare Diseases

PureTech Presents Research Highlighting Burden of Idiopathic Pulmonary Fibrosis (IPF) and Use of a Bayesian Statistical Analysis for LYT-100 (Deupirfenidone) at CHEST 2024 Annual Meeting (PRNewswire) - "PureTech presented qualitative and quantitative research that highlights both the burden of IPF as well as gaps in disease management that exacerbate the quality of life for people with IPF. The 90-person survey found that the majority of participants experience a high burden of disease that interferes with their normal activities, including shortness of breath (86%), fatigue (78%) and cough (77%)...Beyond this, PureTech’s research revealed commonalities and differences in the patient experience for those receiving care at interstitial lung disease (ILD) centers (n=45) versus community pulmonary practices (CPP) (n=45)...Antifibrotic treatment rates at ILD centers and CPPs were similar, but differences existed in perceived communication around antifibrotic treatment options."

Clinical data • Idiopathic Pulmonary Fibrosis • Immunology

PureTech Presents Research Highlighting Burden of Idiopathic Pulmonary Fibrosis (IPF) and Use of a Bayesian Statistical Analysis for LYT-100 (Deupirfenidone) at CHEST 2024 Annual Meeting (Businesswire) - "PureTech also presented a clinical abstract reviewing its plan to evaluate the primary outcome of the Phase 2b ELEVATE IPF clinical trial using a prespecified Bayesian approach...The primary endpoint is the rate of decline in Forced Vital Capacity (FVC) for the combined LYT-100 arms versus placebo over the 26-week treatment period using a Bayesian linear mixed effects model including dynamic borrowing. This approach augments the placebo arm sample size with external placebo data from historical IPF trials. A Bayesian approach has the advantage of enhancing overall statistical power and improving decision-making while limiting the number of patients required to be treated with placebo in a fatal disease."

Clinical protocol • Idiopathic Pulmonary Fibrosis • Immunology

PureTech to Present at CHEST 2024 Annual Meeting (Businesswire) - "PureTech Health plc...announced its onsite presence at the CHEST 2024 Annual Meeting in Boston, Massachusetts, from October 6-9. The Company will deliver two oral presentations and one poster relating to LYT-100 (deupirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF) as well as the Company’s research surrounding the experiences of patients with IPF. The data to be presented have informed the clinical and commercial strategies supporting LYT-100 as well as advocacy and patient engagement work around the management and treatment of people with IPF. Topline results from the Phase 2b ELEVATE IPF trial are expected by the end of 2024."

Clinical • P2b data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease

PureTech Health plc – Half-Year Report (Businesswire) - "PureTech expects topline results from the Phase 2b ELEVATE IPF dose-ranging trial of LYT-100 in patients with IPF by the end of 2024. The trial is designed to evaluate the efficacy, tolerability, safety and dosing regimen of LYT-100 in patients with IPF compared to placebo and will also assess the relative efficacy of two doses of LYT-100....It also expects topline data from its Phase 2 COLLECTiVE202 clinical trial of VE202 for the treatment of ulcerative colitis ('UC')in 2025."

P2 data • P2b data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology

ELEVATE: LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=240 | Active, not recruiting | Sponsor: PureTech | Recruiting ➔ Active, not recruiting

Enrollment closed • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

LYT-100 in Patients With BCRL (clinicaltrials.gov) - P2 | N=50 | Terminated | Sponsor: PureTech | Phase classification: P1/2 ➔ P2

Phase classification • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

Enrollment complete for Phase 2b trial testing LYT-100 in IPF patients (Pulmonary Fibrosis News) - P2 | N=240 | ELEVATE (NCT05321420) | Sponsor: PureTech | "'LYT-100 has the potential to have a profound impact on the way IPF is managed by allowing patients to start, continue and fully benefit from treatment, both as monother...and investigator in the trial, said in a company press release. 'This milestone in the ELEVATE IPF trial is very exciting, and I look forward to the full results as a potential step forward for the large, underserved IPF patient community,' Maher said."

Media quote • P2b data • Idiopathic Pulmonary Fibrosis

PureTech Announces Completion of Enrollment in Phase 2b ELEVATE IPF Trial of LYT-100 (Deupirfenidone) in Idiopathic Pulmonary Fibrosis (Businesswire) - "PureTech Health plc...announced that enrollment has been completed in the ELEVATE IPF Phase 2b clinical trial evaluating LYT-100 (deupirfenidone) in patients with idiopathic pulmonary fibrosis (IPF)....Topline results are expected in the fourth quarter of 2024."

Enrollment closed • P2b data • Fibrosis • Idiopathic Pulmonary Fibrosis • Respiratory Diseases