Phase 2 Trial of Oral Therapy Orelabrutinib Set to Launch in China

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by Patricia Inacio, PhD |

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InnoCare Pharma will soon launch a Phase 2 clinical trial in China to test orelabrutinib, its oral investigational Bruton tyrosine kinase (BTK) inhibitor, to treat neuromyelitis optica spectrum disorder (NMOSD).

The announcement comes after China’s National Medical Products Administration approved the company’s request to conduct such a trial, in the form of an investigational new drug (IND) application.

The study, designed to test orelabrutinib’s safety and effectiveness, will randomly assign participants to either the active treatment or a placebo. Additional details from the trial were not disclosed.

“It remains a challenge to seek efficient treatments for NMOSD, and there is still a large unmet medical need in reducing relapse and improving prognosis,” Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said in a press release.

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“Combining the pathogenesis [disease mechanisms] of NMOSD with the orelabrutinib mechanism, we believe that orelabrutinib will bring a new treatment option for NMOSD,” she added.

NMOSD is an autoimmune disease wherein the immune system erroneously produces antibodies that attack cells from the nervous system, leading to inflammation primarily of the spinal cord and the optic nerves (which connect the eyes to the brain). In more than 80% of patients, this immune attack is driven by antibodies against the AQP4 protein.

Orelabrutinib is an orally available small molecule that blocks BTK activity. This enzyme is important for the survival and activation of several cells of the immune system, most notably B-cells, which are responsible for antibody production.

By inhibiting BTK, orelabrutinib is designed to prevent B-cell activation, thereby lowering antibody production and reducing the inflammatory attacks that cause damage.

Since B-cells are involved in several other autoimmune diseases and in some blood cancers, InnoCare is exploring this medication in conditions such as lupus and multiple sclerosis, as well as in a number of lymphomas. This is being done across a range of clinical studies in the U.S. and China.

The treatment has received approval in China for two forms of blood cancer: chronic lymphocytic leukemia/small lymphocytic lymphoma and mantle cell lymphoma. The approvals cover patients who failed prior treatments.