TCK-276 / Teijin, Elevara Medicines - LARVOL DELTA

ELV001-201: A study to assess the safety and efficacy of different doses of ELV001 to treat active rheumatoid arthritis in patients with an inadequate response to methotrexate and tumor necrosis factor inhibition (START SYNERGY) (clinicaltrialsregister.eu) - P1/2 | N=95 | Not yet recruiting | Sponsor: Elevara Medicines Limited

New P1/2 trial • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • CRP

ELV001-201: A study to assess the safety and efficacy of different doses of ELV001 to treat active rheumatoid arthritis in patients with an inadequate response to methotrexate and tumor necrosis factor inhibition (START SYNERGY) (clinicaltrialsregister.eu) - P1/2 | N=24 | Not yet recruiting | Sponsor: Elevara Medicines Limited

New P1/2 trial • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • CRP

A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY) (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Elevara Medicines Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • CRP

A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY) (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Elevara Medicines Limited

New P2 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Targeting fibroblast-like synoviocytes with CDK4/6 inhibitors as a novel, non-immunosuppressive treatment strategy for rheumatoid arthritis. (PubMed, Clin Exp Rheumatol) - "Therefore, next generation CDK4/6 inhibitors with improved therapeutic index have been designed. A recently published phase 1b study of TCK-276 in RA patients, indicated promising signs of early clinical efficacy and an absence of class-related side effects.This review summarises the molecular biology of CDK4/6, its role in RA pathobiology and discusses how therapeutic CDK4/6 inhibition could form a novel therapeutic class addressing unmet need in the treatment of RA."

Journal • Review • Breast Cancer • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Oncology • Rheumatoid Arthritis • Rheumatology • Solid Tumor

Elevara raises $70M to advance oral rheumatoid arthritis asset (Firstwordpharma Press Release) - "...Elevara Medicines plans to launch a Phase II trial of an oral CDK4/6 inhibitor in patients with rheumatoid arthritis (RA)."

Financing • New P2 trial • Rheumatoid Arthritis

A double-blind, placebo-controlled, randomized multiple dose phase 1b trial of a CDK4/6 inhibitor, TCK-276, in patients with active rheumatoid arthritis. (PubMed, Rheumatology (Oxford)) - P1 | "TCK-276 (≤175 mg) was well tolerated with no clinically meaningful safety signals in patients with active RA. Together with the preliminary efficacy (≥25 mg/day), these data warrant further study of TCK-276 for the treatment of active RA."

Journal • P1 data • Hematological Disorders • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Safety, Tolerability, and Pharmacokinetics of a Novel Synthetic Disease Modifying Antirheumatic Drug, TCK-276, After Single Ascending Dose in Healthy Subjects and Multiple Ascending Doses in Patients with Rheumatoid Arthritis (ACR Convergence 2023) - P1 | "Safety results indicated that TCK-276 was well tolerated at a dose of up to 185 mg for a single administration and up to 25 mg/day over 7 days of administration. In addition, no safety concerns have been observed such as anemia, neutropenia, leukopenia, and thrombocytopenia, which are often observed with other CDK4/6 inhibitors. TCK-276 showed faster elimination than other CDK4/6 inhibitors, which may be related to the observed safety profile."

Clinical • PK/PD data • Anemia • Hematological Disorders • Immunology • Inflammatory Arthritis • Leukopenia • Neutropenia • Pain • Rheumatoid Arthritis • Rheumatology • Thrombocytopenia

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Teijin America, Inc. | Recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Teijin America, Inc. | Trial completion date: Jan 2023 ➔ Jun 2023 | Trial primary completion date: Jan 2023 ➔ Jun 2023

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Teijin America, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Teijin America, Inc.

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology