InnoCare announces approval of phase II clinical trial using orelabrutinib for the treatment of ITP in China
BEIJING, August 10, 2021 / PRNewswire / – InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, today announced the approval of an investigational new drug (IND) of its tyrosine kinase (BTK) inhibitor from Bruton, orelabrutinib by the China National Medical Products Administration (NMPA) for the start-up phase II clinical trial in primary immune thrombocytopenia (ITP) in China.
This is a randomized, multicenter, adaptive phase IIa / IIb study to evaluate the efficacy and safety of orelabrutinib in adult patients with ITP.
Primary Immune Thrombocytopenia (ITP), also called idiopathic thrombocytopenic purpura, is an acquired immune-mediated disease characterized by a decrease in the number of peripheral blood platelets, leading to an increased risk of bruising and bleeding.[i].
The main pathogenesis of ITP is the loss of immune tolerance to platelet autoantigens. This immune intolerance leads to increased destruction of platelets and decreased production of platelets from megakaryocytes by autoantibodies and cytotoxic T lymphocytes. BTK is a key kinase in the B cell receptor signaling pathway, which is essential for the activation of B lymphocytes, macrophages and other immune cells as well as for the production of antibodies in the pathological process of ITP.
The annual incidence rate of ITP in adults is approximately 2 to 10 new cases per 100,000 population per year[ii],[iii]. It is more common in patients over 60 years old. Women of childbearing age have a higher risk of ITP than men of the same age group.
Dr. Jasmine cui, Co-Founder, President and CEO of InnoCare, said: “Worldwide, no BTK inhibitors have been approved for the treatment of patients with ITP. Orelabrutinib has high target selectivity with a safety profile, which should provide new treatment options for patients with ITP. “
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancer and autoimmune diseases.
On December 25th, orelabrutinib has received approval from the China National Medical Products Administration (NMPA) for two indications: the treatment of patients with relapsed / refractory chronic lymphocytic leukemia (CLL) / small lymphocyte lymphoma (SLL) and treatment of patients with relapsed / refractory mantle cell lymphoma (MCL). The two New Drug Applications (NDAs) have already been given priority review by the NMPA Center for Drug Evaluation (CDE).
In addition to the approved indications, multi-center and multi-indication clinical trials are underway in the United States and China with orelabrutinib as monotherapy or in combination.
InnoCare is a commercial-stage biopharmaceutical company engaged in the discovery, development and commercialization of first-class and / or first-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on lymphomas, solid tumors and autoimmune diseases with high unmet medical needs in China and around the world. InnoCare has branches in Beijing, Nankeen, Shanghai, Canton, New Jersey, and Boston.
[i] Thrombosis and Hemostasis Group, Chinese Society of Hematology, Chinese Medical Association. Chinese guideline for the diagnosis and management of primary immune thrombocytopenia in adults (2020 version). Zhonghua Xue Ye Xue Za Zhi. 2020, 41 (8): 617-623.
[ii] Lee JY, Lee JH, Lee H, et al. Epidemiology and management of primary immune thrombocytopenia: a national population-based study in Korea. Thromb Res. 2017, 155: 86-91.
[iii] Moulis G, Palmaro A, Montastruc JL, et al. Epidemiology of incident immune thrombocytopenia: national study in the French population. Blood. 2014, 124 (22): 3308-3315.