fepixnebart (LY3016859) / Eli Lilly - LARVOL DELTA

Population Pharmacokinetics and Pharmacodynamics of Fepixnebart (LY3016859) and Epiregulin in Patients with Chronic Pain. (PubMed, Clin Pharmacokinet) - P2 | "The phase 2 dose regimen is adequate to test the analgesic effect of fepixnebart in patients with osteoarthritis, DPNP, and CLBP. In the final model, female sex and higher glomerular filtration rate were associated with higher clearance, female sex was associated with larger volume of distribution of the central compartment (Vc) than male sex, and DPNP was associated with lower Vc than CLBP. There were no significant effects on the concentration of fepixnebart at which its effect on epiregulin is half-maximal (EC50)."

Journal • PK/PD data • Back Pain • Diabetic Nephropathy • Diabetic Neuropathy • Immunology • Lumbar Back Pain • Musculoskeletal Pain • Nephrology • Neuralgia • Oncology • Osteoarthritis • Pain • Peripheral Neuropathic Pain • Renal Disease • Rheumatology • EREG

Operational Benefits of the Chronic Pain Master Protocol Platform Trial (IASP 2024) - "It assessed safety and efficacy of 4 potential novel chronic pain interventions (LY3016859 Epiregulin/TGF? monoclonal antibody, LY3526318 transient receptor potential ankyrin 1 antagonist, LY3556050 somatostatin receptor 4 antagonist and LY3857210 purinergic 2X7 antagonist) vs placebo in patients with osteoarthritis of the knee, chronic low back pain and diabetic peripheral neuropathic pain... The CPMP design enables efficient testing of multiple investigational interventions across a variety of pain types while allowing study interventions to be added at different time points across patient populations. At the same time, the use of standardized design elements and dedicated resources within the overall context of this flexible design resulted in reduced enrollment timelines and operational efficiencies at several levels."

Clinical • Back Pain • Diabetic Neuropathy • Immunology • Lumbar Back Pain • Musculoskeletal Pain • Neuralgia • Osteoarthritis • Pain • Peripheral Neuropathic Pain • Rheumatology • EREG • SSTR

CPMP: A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain (clinicaltrials.gov) - P2 | N=10000 | Recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Back Pain • Diabetic Neuropathy • Immunology • Lumbar Back Pain • Musculoskeletal Pain • Neuralgia • Osteoarthritis • Pain • Rheumatology

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2; N=125; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting ➔ Completed; Trial completion date: Jan 2023 ➔ Nov 2021

Clinical • Trial completion • Trial completion date • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Osteoarthritis (clinicaltrials.gov) - P2; N=117; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting ➔ Completed; Trial completion date: Sep 2022 ➔ Aug 2021

Clinical • Trial completion • Trial completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back Pain (clinicaltrials.gov) - P2; N=149; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting ➔ Completed; Trial completion date: Nov 2022 ➔ Oct 2021

Clinical • Trial completion • Trial completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2; N=125; Active, not recruiting; Sponsor: Eli Lilly and Company; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back Pain (clinicaltrials.gov) - P2; N=150; Active, not recruiting; Sponsor: Eli Lilly and Company; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Osteoarthritis (clinicaltrials.gov) - P2; N=125; Active, not recruiting; Sponsor: Eli Lilly and Company; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Immunology • Osteoarthritis • Pain • Rheumatology

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2; N=125; Recruiting; Sponsor: Eli Lilly and Company; Trial completion date: Mar 2022 ➔ Jan 2023; Trial primary completion date: Mar 2021 ➔ Aug 2021

Clinical • Trial completion date • Trial primary completion date • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back Pain (clinicaltrials.gov) - P2; N=150; Recruiting; Sponsor: Eli Lilly and Company; Trial completion date: May 2022 ➔ Nov 2022

Clinical • Trial completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Osteoarthritis (clinicaltrials.gov) - P2; N=125; Recruiting; Sponsor: Eli Lilly and Company; Trial completion date: Mar 2022 ➔ Sep 2022

Clinical • Trial completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back Pain (clinicaltrials.gov) - P2; N=150; Recruiting; Sponsor: Eli Lilly and Company; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back Pain (clinicaltrials.gov) - P2; N=150; Not yet recruiting; Sponsor: Eli Lilly and Company

New P2 trial • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2; N=125; Recruiting; Sponsor: Eli Lilly and Company

Clinical • New P2 trial • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Osteoarthritis (clinicaltrials.gov) - P2; N=125; Recruiting; Sponsor: Eli Lilly and Company

Clinical • New P2 trial • Immunology • Osteoarthritis • Pain • Rheumatology

Evaluation of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy After Single and Multiple Dosings of LY3016859 in Healthy Subjects and Patients With Diabetic Nephropathy. (PubMed, Clin Pharmacol Drug Dev) - "There was no obvious effect of LY on the disease-related biomarkers monocyte chemoattractant protein-1, synaptopodin, or transferrin. Although LY administration resulted in a high frequency of anti-LY antibodies, pharmacokinetics, target engagement, and efficacy were not impacted."

Biomarker • Clinical • Journal • PK/PD data