admilparant (BMS-986278) / BMS - LARVOL DELTA

A Study to Assess the Effect of Food on the Drug Levels of Admilparant (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial

Admilparant: Data readout from P3 ALOFT-PPF trial (NCT06025578) for progressive pulmonary fibrosis in 2027 (Bristol-Myers Squibb) - Q3 2025 Results

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=27 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed

Trial completion • 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 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed

Trial completion

Plasma proteomic analysis in patients with idiopathic pulmonary fibrosis (IPF) from a phase 2 trial of admilparant (ERS 2025) - P2 | "Plasma proteomic analysis showed admilparant reduced biomarkers of fibrosis and upregulated markers associated with mitochondrial and metabolic pathways in pts with IPF, suggesting pathway normalization. These findings expand our understanding of potential mechanisms of admilparant action and identify biomarkers that may help evaluate treatment response and disease activity in IPF."

Clinical • Omic analysis • P2 data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • CKMT1A • CTHRC1 • IGFBP6

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

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

Admilparant: Data readout from P3 ALOFT-IPF trial (NCT06003426) for idiopathic pulmonary fibrosis in 2026 (Bristol-Myers Squibb) - Q2 2025 Results: Data readout from P3 ALOFT-PPF trial (NCT06025578) for progressive pulmonary fibrosis in 2028

P3 data • Idiopathic Pulmonary Fibrosis

Unmet needs and emerging pharmacotherapies for autoimmune connective tissue disease-associated interstitial lung diseases. (PubMed, Autoimmun Rev) - "Due to the scarcity of randomized clinical trials for CTD-ILD, many pharmacotherapies are generally administered off-label (although several are approved in Japan), with notable exceptions including nintedanib, an anti-fibrotic agent approved for SSc-ILD and chronic progressive fibrosing ILD in several countries...Promising compounds in clinical trials include nerandomilast (a preferential phosphodiesterase 4B inhibitor), admilparant (a lysophosphatidic acid receptor 1 antagonist), and inhaled treprostinil (a prostacyclin analogue). Nerandomilast may have both anti-fibrotic and immunomodulatory properties; in preclinical models of PPF, it reduced neutrophils and macrophages and down-regulated pro-fibrotic signaling pathways. Hopefully, therefore, this pipeline will produce new medications to ease the collectively large burden of CTD-ILD and PPF."

Clinical • Journal • Review • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Sclerosis

Design, Synthesis and Discovery of a second-generation PET Ligand for Lysophosphatidic Acid Receptor 1 (LPA1) to Measure Target Engagement of LPA1 Antagonists in Lung Tissues (SNMMI 2025) - "Ligand candidates were successfully synthesized with either C-11 or F-18, with high radiochemical purity (>95%), molar activities above 37 MBq/nmol, higher free fractions (> 10% free in rodent plasma) and demonstrated high LPA1 affinity. From these studies, [18F]BMS-986327 demonstrated the highest signal to noise within the bleomycin treated rodent model (a 58% increase compared to WT). Target engagement PET studies showed a clear correlation between radioligand signal in the lung of bleomycin treated rats and the plasma concentration of an administered LPA1 antagonist (either BMS-986278 and BMS-986020)."

Fibrosis • 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

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

Admilparant for Managing Disease Progression in IPF and PPF (Physician’s Weekly) - P2 | N=403 | NCT04308681 | Sponsor: Bristol-Myers Squibb | "This phase 2, randomized, double-blind, placebo-controlled trial included separate cohorts of patients diagnosed with IPF or PPF....A total of 255 patients with IPF and 114 patients with PPF were enrolled in the study. The median baseline ppFVC was 77.3% in the IPF cohort and 64.7% in the PPF cohort. In both groups, treatment with 60 mg of admilparant significantly delayed disease progression compared to placebo. For patients with IPF, the disease progression was 0.54 (95% CI, 0.31–0.95), and for patients with PPF, the HR was 0.41 (95% CI, 0.18–0.90). These results were consistent across subgroups based on baseline ppFVC values, both above and below the median."

P2 data • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

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