LY3857210 / Eli Lilly, Asahi Kasei, RaQualia - LARVOL DELTA

AK1780, a selective P2X7 receptor antagonist with high central nervous system penetration, exhibits analgesic effect in rat neuropathic pain model. (PubMed, J Pain) - "PERSPECTIVE: This article presents in vitro and in vivo data for AK1780 (LY3857210), a selective P2X7R antagonist. The data reasonably explain its analgesic effect in the view of PK/PD, indicating that AK1780 may potentially suppress neuropathic pain without any CNS adverse effects."

Journal • Preclinical • Neuralgia • Pain • IL1B

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

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05) (clinicaltrials.gov) - P2 | N=131 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

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

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

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05) (clinicaltrials.gov) - P2 | N=125 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

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

OA05: A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain (clinicaltrials.gov) - P2 | N=147 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back Pain (clinicaltrials.gov) - P2 | N=138 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back Pain (clinicaltrials.gov) - P2 | N=125 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

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

OA05: A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain (clinicaltrials.gov) - P2 | N=125 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Lilly and Asahi Kasei Pharma Announce License Agreement for Chronic Pain Drug Candidate (Eli Lilly Press Release) - "Eli Lilly...and Asahi Kasei Pharma Corporation today announced a license agreement whereby Lilly will acquire the exclusive rights for AK1780 from Asahi Kasei Pharma...recently completed Phase 1 single and multiple ascending dose and clinical pharmacology studies. P2X7 receptors have been consistently implicated in neuroinflammation, a driving force in chronic pain conditions....Under the terms of the agreement, Lilly will be responsible for future global development and regulatory activities for AK1780...upfront payment of $20 million and Asahi Kasei Pharma may be eligible for up to $210 million in potential development and regulatory milestones."

Licensing / partnership • Pain

A Study of LY3857210 in Healthy Participants (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Eli Lilly and Company | Recruiting ➔ Completed | N=25 ➔ 10

Enrollment change • Trial completion

OA05: A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain (clinicaltrials.gov) - P2 | N=125 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back Pain (clinicaltrials.gov) - P2 | N=125 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

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

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05) (clinicaltrials.gov) - P2 | N=125 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05) (clinicaltrials.gov) - P2 | N=125 | Not yet recruiting | Sponsor: Eli Lilly and Company

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

OA05: A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain (clinicaltrials.gov) - P2 | N=125 | Not yet recruiting | Sponsor: Eli Lilly and Company

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

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back Pain (clinicaltrials.gov) - P2 | N=125 | Not yet recruiting | Sponsor: Eli Lilly and Company

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

A Study of LY3857210 in Healthy Participants (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Jun 2022 ➔ Sep 2022 | Trial primary completion date: Jun 2022 ➔ Sep 2022

Trial completion date • Trial primary completion date