admilparant (BMS-986278) / BMS - LARVOL DELTA

Design and Rationale for a Phase 3 Trial of Admilparant (BMS-986278), An Oral Lysophosphatidic Acid Receptor 1 Antagonist, in Patients With Idiopathic Pulmonary Fibrosis: ALOFT-IPF (ATS 2025) - P3 | "Background antifibrotic treatment (nintedanib or pirfenidone) is permitted. This ALOFT-IPF trial will determine the effect of admilparant on safety, FVC, disease progression and quality-of-life over ≥52 weeks in patients with IPF. Trial registration number: NCT06003426"

Clinical • P3 data • Cough • Fibrosis • Hypotension • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Design and Rationale of a Phase 3 Trial for Admilparant (BMS-986278), an Oral Lysophosphatidic Acid Receptor 1 Antagonist, in Patients With Progressive Pulmonary Fibrosis: ALOFT-PPF (ATS 2025) - P3 | "ALOFT-PPF will determine the effect of admilparant on safety, FVC, disease progression and quality-of-life over ≥52 weeks in patients with PPF. Trial registration number: NCT06025578"

Clinical • P3 data • Cough • Fibrosis • Hypotension • Immunology • Infectious Disease • Interstitial Lung Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Effect of Admilparant, an LPA1 Antagonist, on Disease Progression in Pulmonary Fibrosis. (PubMed, Chest) - "These findings support further evaluation of admilparant as a therapeutic option for patients with IPF or PPF in phase 3 trials."

Clinical • Journal • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate Comparative Bioavailability of BMS-986278 in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed

Trial completion

A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy Participants (clinicaltrials.gov) - P1 | N=71 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed

Trial completion

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effects of BMS-986278 on Cardiac Repolarization in Healthy Participants (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open

Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic Impairment (clinicaltrials.gov) - P1 | N=37 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed

Trial completion • Hepatology

A Study to Evaluate Comparative Bioavailability of BMS-986278 in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open

Admilparant: Data readout from P3 ALOFT-IPF trial (NCT06003426) for IPF in 2026 (Bristol-Myers Squibb, 43rd Annual J.P. Morgan Healthcare Conference) - Data readout from P3 ALOFT-PPF trial (NCT06025578) for progressive pulmonary fibrosis in 2028

P3 data • Idiopathic Pulmonary Fibrosis

Admilparant: Data readout from P3 ALOFT-IPF trial (NCT06003426) for IPF in 2026 (Bristol-Myers Squibb, 43rd Annual J.P. Morgan Healthcare Conference) - Data readout from P3 ALOFT-PPF trial (NCT06025578) for progressive pulmonary fibrosis in 2028

P3 data • Idiopathic Pulmonary Fibrosis

A Study to Evaluate BMS-986278 in Participants With Normal Renal Function, Severe Renal Impairment, or End-Stage Renal Disease on Intermittent Hemodialysis (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effects of BMS-986278 on Cardiac Repolarization in Healthy Participants (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

A Study to Evaluate BMS-986278 in Participants With Normal Renal Function, Severe Renal Impairment, or End-Stage Renal Disease on Intermittent Hemodialysis (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial • Chronic Kidney Disease • Nephrology • Renal Disease

A Study to Evaluate Comparative Bioavailability of BMS-986278 in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

Targeting Autotaxin and LPA in Pulmonary Fibrosis: Admilparant's Positive Results Show Continued Promise. (PubMed, Am J Respir Crit Care Med) - No abstract available

Journal • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Ninetedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy Participants (clinicaltrials.gov) - P1 | N=73 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open

Efficacy and Safety of Admilparant, an LPA1 Antagonist in Pulmonary Fibrosis: A Phase 2 Randomized Clinical Trial. (PubMed, Am J Respir Crit Care Med) - P2 | "In this first phase 2 study to evaluate antifibrotic treatment in parallel IPF and PPF cohorts, 60-mg admilparant slowed lung function decline and was safe and well tolerated, supporting further evaluation in phase 3 trials. Clinical trial registration available at www."

Clinical • Journal • P2 data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

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

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis (clinicaltrials.gov) - P3 | N=1092 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P3 | N=1185 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

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

Admilparant Affects Biomarkers in Pulmonary Fibrosis (Medscape) - "Additional research is needed, but the current results suggest that the biomarkers in patients with IPF and PFF may be used to monitor treatment response and disease progression in future trials for pulmonary fibrosis treatments, Maher said in his presentation."

Biomarker • Media quote • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

Effects of lysophosphatidic acid receptor 1 (LPA1) antagonism on biomarkers in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF): data from a randomized phase 2 trial with BMS-986278 (ERS 2024) - P2 | "Treatment with BMS-986278 over 26 weeks significantly improved biomarkers of epithelial injury and fibrosis in patients with IPF, and biomarkers of inflammation and fibrosis in patients with PPF, consistent with effective antagonism of the LPA1 pathway."

Biomarker • Clinical • P2 data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CHI3L1 • MMP7 • POSTN • TGFB1 • VCAM1

Emerging pharmacological options in the treatment of idiopathic pulmonary fibrosis (IPF). (PubMed, Expert Rev Clin Pharmacol) - "Currently, two agents, pirfenidone and nintedanib are approved for this disease, and both have been shown to reduce the rate of decline in lung function in patients with IPF...It is expected that the adverse drug effect profiles will be more favorable than current agents. It is further anticipated that these new agents or combinations of agents will arrest the fibrosis, not just slow the fibrotic process."

Journal • Review • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Ninetedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy Participants (clinicaltrials.gov) - P1 | N=73 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

Evidence from recent clinical trials in fibrotic interstitial lung diseases. (PubMed, Curr Opin Pulm Med) - "Despite recent frustrating negative results, there is a growing portfolio of candidate drugs developed in both IPF and PPF."

Journal • Review • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • CTGF