Telitacicept found to ease primary Sjogren’s severity in Phase 2 clinical trial

Injection therapy at lower dose significantly lessens disease activity

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Telitacicept, RemeGen’s experimental under-the-skin injection therapy, significantly reduced disease severity in adults with primary Sjögren’s syndrome (pSS), according to final data from a Phase 2 clinical trial.

Results were detailed in the study “Efficacy and safety of telitacicept in primary Sjögren’s syndrome: a randomized, double-blind, placebo-controlled, phase 2 trial,” published in the journal Rheumatology.

“RemeGen is delighted with these published breakthrough findings that offer new hope for pSS treatment,” Jianmin Fang, PhD, RemeGen’s co-founder, CEO, and chief science officer, said in a company press release.

“We fully expect telitacicept to enter the market imminently, bringing much-needed new hope to patients all over the world,” Fang added.

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Telitacicept blocks the activity of two proteins that activate immune cells

An autoimmune disease, Sjögren’s is characterized by the abnormal production of self-reactive antibodies that wrongly attack healthy tissue, most commonly the tear and salivary glands. Disease symptoms can include dry eyes and mouth as well as pain and fatigue. More severe cases can affect internal organs such as the kidneys and lungs.

Telitacicept, also known as RC18, is a synthetic molecule created by fusing pieces of a type of antibody called immunoglobulin G and a protein called TACI. It is designed to block the activity of two proteins — BLyS and APRIL — involved in the inflammatory activation of immune cells, particularly antibody-producing B-cells.

By suppressing these proteins, telitacicept is expected to reduce the autoimmune and inflammatory attack on healthy tissue that drives pSS and other autoimmune diseases.

The therapy was conditionally approved in China for people with lupus, another autoimmune disease, in 2021.

The RemeGen-sponsored Phase 2 trial (NCT04078386) evaluated the therapy’s safety and effectiveness in 42 adults with pSS, enrolled at a single site in China. Participants were randomly assigned to a subcutaneous injection of telitacicept at either 160 or 240 mg or to a placebo injection, given once weekly for about six months.

Its main goal was to determine whether telitacicept could lower disease activity, as assessed by the European League Against Rheumatism’s Sjögren’s syndrome disease activity (ESSDAI) scores. ESSDAI is a standardized measure that evaluates the impact of Sjögren’s across different bodily systems, with higher scores indicating greater disease activity.

Significant ESSDAI score drop among Primary Sjögren’s patients given low dose

Trial results, announced by the company in 2022, showed that telitacicept’s lower dose was significantly superior to a placebo at reducing disease severity. Specifically, the lower dose led to a statistically significant drop of 4.3 points on the ESSDAI score, on average, relative to a placebo.

Among patients given the higher dose of telitacicept, ESSDAI scores dropped by an average of 2.7 points relative to those on a placebo. However, this difference failed to reach statistical significance, meaning it’s mathematically plausible the difference could be due to chance rather than the effects of treatment.

Both doses of telitacicept led to significant reductions in fatigue compared with a placebo, based on changes in the 20-question Multidimensional Fatigue Inventory score.

Blood antibody levels also decreased significantly in patients given either dose of telitacicept, in line with the therapy’s mechanism of action to reduce B-cells activity.

Results also suggested that telitacicept was generally well tolerated, and no serious side effects or deaths reported.

Collectively the results demonstrate that “telitacicept showed clinical benefits and good tolerance and safety in the treatment of pSS,” the researchers wrote.

“As a new drug with significant potential, telitacicept Phase II clinical study data has been published in top international journals, which is major proof of our research and development capabilities,” Fang said.