Enrollment Completed in Clinical Trials for Primary Sjögren’s Syndrome and IgA Nephropathy

Jianmin Fang, M.D. the CEO of the biotechnology company RemeGen, recently announced in PRNewswire that the company is continuing its significant progress in its research of Telitacicept (RC18) to treat primary Sjögren’s syndrome and IgA nephropathy. Patient enrollment is now complete for both trials.

About IgA Nephropathy

IgA nephropathy currently has no cure. It is caused by an accumulation of the protein immunoglobulin A (IgA) that causes inflammation in the patient’s kidneys and diminishes the kidneys’ ability to filter waste.

About the Two Phase 3 Trials

Between June 2023 and May 2024, 318 people were enrolled in the study that was conducted at Peking University. It was led by Zhang Hong M.D, a professor at the university. Patient enrollment has been completed in both trials. The researchers have been evaluating the safety and efficacy of RC18 when treating patients who have IgA nephropathy and face the risk of progressing to end-stage kidney disease. Pre-filled injections were used for the trial providing a convenient method to administer the medication as opposed to the currently approved lyophilized (freeze dried) powder injection.

About Primary Sjögren’s Syndrome (pSS)

Sjögren’s syndrome is a chronic and slowly progressive autoimmune disorder that eventually destroys cells in the salivary glands and cells that produce tears. As the disease progresses, it may produce other manifestations reflecting damage to other organs such as kidneys, joints, lungs, and peripheral nerves. B-cells have long been acknowledged as the primary immune cells that are critical to the development (pathogenesis) of the disease. Therefore, B-cells are regarded as important intervention targets.

About the Second Study

Beginning in 2022 and ending in May of 2024, Zeng Xiaofeng M.D., professor at the Chinese Academy of Medical Sciences led the second clinical study. It also was designed to assess the safety and efficacy of RC18 treating people with Sjögren’s, a common rheumatic disease, from baseline to the 24th week of the treatment. RC18 is building on a substantial benefit it displayed previously in a Phase II trial for adults diagnosed with the syndrome. Immunoglobulin levels were reduced in those participants.

The Primary Endpoints

RC18 demonstrated a significant benefit in a previous Phase II trial after treating patients who have pSS. Based on various patient responses, RC18 was found to have reduced levels of immunoglobulin in participants.

About RC18

RC18 is RemeGen’s fusion protein designed to treat autoimmune disorders. Two cell-signaling molecules are targeted that are vital to B-lymphocyte development. They reduce B-cell autoimmune responses implicated in several autoimmune disorders. RemeGen Co. is a prominent biopharmaceutical company based in China with laboratories in the United States. The company is committed to finding solutions for the unmet needs of people facing life-threatening illnesses.

Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia (AML) six years ago. During this period of partial remission, Rose researched investigational drugs to be prepared in the event of a relapse. Her husband died February 12, 2021 with a rare and unexplained occurrence of liver cancer possibly unrelated to AML.

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