cevidoplenib (SKI-O-703) / Oscotec - LARVOL DELTA

A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies. (clinicaltrials.gov) - P2 | N=163 | Completed | Sponsor: Oscotec Inc. | Unknown status ➔ Completed

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

FDA Grants Orphan Drug Designation to Cevidoplenib for ITP (PRNewswire) - "Oscotec Inc. has secured orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its SYK inhibitor, Cevidoplenib, to treat immune thrombocytopenia (ITP)."

Orphan drug • Thrombocytopenic Purpura

Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP) (clinicaltrials.gov) - P2 | N=61 | Completed | Sponsor: Oscotec Inc. | Unknown status ➔ Completed | Trial completion date: Feb 2021 ➔ Jan 2023 | Trial primary completion date: Feb 2021 ➔ Jan 2023

Trial completion • Trial completion date • Trial primary completion date • Hematological Disorders • Thrombocytopenia • Thrombocytopenic Purpura

CEVIDOPLENIB, A SELECTIVE INHIBITOR OF SPLEEN TYROSINE KINASE (SYK), IN PERSISTENT AND CHRONIC IMMUNE THROMBOCYTOPENIA (ITP): EFFICACY AND SAFETY IN A MULTICENTER, PLACEBO CONTROLLED PHASE 2 STUDY (EHA 2023) - P2 | "Cevidoplenib 400 mg twice daily was generally well tolerated and demonstrated robust platelet responses in asignificant proportion of participants who had failed multiple prior therapies. It warrants further clinical studies ina larger number of participants for an extended period to confirm durability of the clinical benefits."

Clinical • Late-breaking abstract • P2 data • Hematological Disorders • Immunology • Thrombocytopenia • Thrombocytopenic Purpura • SYK

CEVIDOPLENIB (SKI-O-703), A NOVEL SYK INHIBITOR, REDUCES ANTIPHOSPHOLIPID ANTIBODY TITERS AND PREVENTS INTRAMYOCARDIAL SMALL ARTERIAL THROMBOSIS IN A MOUSE MODEL OF ANTIPHOSPHOLIPID SYNDROME (EHA 2023) - "Most pathological signs of APS, especially that of cardiac histology, were significantly improved by administration of cevidoplenib in the mouse model. Specific inhibition of SYK appears to be a promising immunotherapeutic, disease-modifying approach to lowering the risk of thrombotic events in APS patients. Antiphospholipid syndrome, SYK, Antiphospholipid antibody"

Preclinical • Cardiovascular • Genetic Disorders • Hematological Disorders • Immunology • Inflammatory Arthritis • Myocardial Infarction • Obstetrics • Thrombocytopenia • Thrombocytopenic Purpura • Thrombosis • SYK

"Cevidoplenib Elicits Platelet Responses in Persistent or Chronic Immune Thrombocytopenia @EHA_Hematology #EHA2023 #oncology https://t.co/8AKZRapHnR" (@OncLive)

Hematological Disorders • Oncology • Thrombocytopenia • Thrombocytopenic Purpura

A novel selective spleen tyrosine kinase inhibitor SKI-O-703 (cevidoplenib) ameliorates lupus nephritis and serum-induced arthritis in murine models. (PubMed, Clin Exp Immunol) - "This effect was recapitulated when mice otherwise refractory to anti-TNF therapy were treated by TNF blockade combined with a suboptimal dose of SKI-O-703. These results demonstrate that the novel selective Syk inhibitor SKI-O-703 attenuates the progression of autoantibody-mediated autoimmune diseases by inhibiting both autoantibody-producing and autoantibody-sensing cells."

Journal • Preclinical • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • SYK

Recent advances in understanding spleen tyrosine kinase (SYK) in human biology and disease, with a focus on fostamatinib. (PubMed, Platelets) - "SYK inhibitors have the potential to target several aspects of COVID-19 pathogenesis including thrombosis, without affecting normal hemostasis, and data from the first study of fostamatinib in COVID-19 are encouraging. It is hoped that ongoing trials in autoimmune indications other than ITP, as well as in hematological malignancies and other disorders, confirm the promise of SYK inhibitors."

Journal • Autoimmune Hemolytic Anemia • Cardiovascular • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Novel Coronavirus Disease • Oncology • Thrombocytopenia • Thrombocytopenic Purpura • Thrombosis • SYK

A Study of the Absorption, Metabolism, and Excretion of [14C]-SKI-O-703 Following a Single Oral Dose in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Oscotec Inc. | Recruiting ➔ Completed

Trial completion

A Study of the Absorption, Metabolism, and Excretion of [14C]-SKI-O-703 Following a Single Oral Dose in Healthy Male Subjects (clinicaltrials.gov) - P1; N=8; Recruiting; Sponsor: Oscotec Inc.

Clinical • New P1 trial

A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies. (clinicaltrials.gov) - P2; N=148; Active, not recruiting; Sponsor: Oscotec Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Apr 2020 ➔ Oct 2020; Trial primary completion date: Apr 2020 ➔ Oct 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

New funding awards - September 2019 (Duke University School of Medicine) - "Ara Metjian of Hematology has received an award from Oscotec, Inc. for a project entitled 'Phase II, of oral SKI-O-703 in Chronic Immune Thrombocytopenia (ITP).' Total funding will be $148,045."

Announcement • Grant

Anti-inflammatory Effect of Novel Spleen Tyrosine Kinase Inhibitor, SKI-O-592, on Fibroblast-like Synoviocyte in Rheumatoid Arthritis and THP-1 Cell (ACR-ARHP 2019) - "The novel SYK inhibitor, SKI-O-592 decreased the production of pro-inflammatory cytokine, chemokine and metalloproteinase in RA FLS. SKI-O-592 decreased the phosphorylation of PI3K. SKI-O-592 may provide a new therapeutic strategy in RA patients."

Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP) (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Oscotec Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies. (clinicaltrials.gov) - P2; N=148; Recruiting; Sponsor: Oscotec Inc.

Clinical • New P2 trial

Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP) (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: Oscotec Inc.

New P2 trial

Oscotec launches phase 2 clinical trial for rheumatoid arthritis [Google Translation] (Yakup.com) - "SK-O-703...has been started to be administered to clinical patients for rheumatoid arthritis....Targets 59 patients in the world, including 14 hospitals in the US, 10 hospitals in Korea, and 35 hospitals in five European countries and the first patient dosing in the United States began."

Trial status