InnoCare Pharma begins patient dosing in phase III registrational trial of orelabrutinib for treatment of ITP in China

InnoCare Pharma, a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced that the first patient has been dosed in the phase III registrational trial of the company’s BTK (Bruton Tyrosine Kinase) inhibitor orelabrutinib for the treatment of primary immune thrombocytopenia (ITP) in China.

According to the data presented at the European Haematology Association (EHA) 2023 Hybrid Congress (abstract number: S299), the phase II study results showed that both 50mg QD and 30mg QD of orelabrutinib were safe in the treatment of patients with ITP, with 40 percent of patients at the 50mg arm meeting the primary endpoint.

Orelabrutinib, a novel BTK inhibitor developed by InnoCare, has high target selectivity and a good safety profile, which makes it suitable for the development of various autoimmune diseases. Currently, there are no BTK inhibitors approved for the treatment of ITP in the world.

Dr. Jasmine Cui, co-founder, chairwoman, and CEO of InnoCare, said, “BTK inhibitors like orelabrutinib hold the promise of revolutionizing ITP treatment by markedly decreasing platelet destruction and reducing the production of pathogenic autoantibodies. Orelabrutinib has consistently demonstrated a promising efficacy and safety profile in treating autoimmune diseases, including ITP. We are committed to expediting its clinical development, aiming to offer new therapeutic avenues to patients grappling with autoimmune disorders such as ITP as early as possible.”

ITP is an acquired immune mediated disorder characterized by a decrease in peripheral blood platelet counts, resulting in an increased risk of bruising and bleeding. The annual incidence rate of adult ITP is about 2-10 per 100,000 people. Only about 70% of patients respond to first-line treatment. Therefore, it is necessary to explore new therapies. It is expected that orelabrutinib has potential to provide a better treatment option for ITP patients.

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.

On December 25, 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukaemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients. On Nov. 22, 2022, orelabrutinib was approved for the treatment of R/R MCL in Singapore. On April 20, 2023, orelabrutinib was approved for the treatment r/r MZL in China.

In addition to the approved indications, multi-centre, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies, such as first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL).

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA). Patient enrollment of phase II registrational trial for R/R MCL was completed in the US. The company expects to submit the NDA to the US Food and Drug Administration (FDA) in the middle of 2024.

In addition, the company has achieved proof of concept (PoC) of orelabrutinib for the treatment of primary immune thrombocytopenia purpura (ITP) and the phase III registrational trial is ongoing in China. Orelabrutinib’s global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE achieved proof of concept (PoC), and orelabrutinib’s phase II study for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) is ongoing in China.

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide.

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