Telitacicept Shows Signs of Efficacy, Safety in Phase 2 Trial in MG Adults

Therapy candidate found to ease disease severity in AChR-positive patients

Patricia Inacio, PhD avatar

by Patricia Inacio, PhD |

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Nearly six months of treatment with telitacicept (RC18), an anti-inflammatory developed by RemeGen, safely lessened disease severity in adults with myasthenia gravis (MG) positive for acetylcholine receptor (AChR) antibodies.

That’s according to new data from an ongoing Phase 2 trial in China.

“The latest Phase II clinical study results show the use of our proprietary novel fusion protein telitacicept in the treatment of MG in Chinese patients has the potential to profoundly address the unmet clinical needs of countless patients in China and around the globe,” Jianmin Fang, PhD, CEO and chief scientific officer of RemeGen, said in a press release.

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RemeGen has announced that its experimental therapy Telitacicept has been awarded orphan drug status by the U.S. Food and Drug Administration.

Telitacicept Wins Orphan Drug Status to Treat Myasthenia Gravis

Trial ongoing in China

In MG, self-reacting antibodies, which are produced by a type of immune cell called B-cells, interfere with the communication between nerve and muscle cells. This causes muscle weakness and other symptoms that typically worsen with repetitive movement. The most common type of MG-driving antibody targets the acetylcholine receptor, known as AChR.

Telitacicept was designed to reduce the inflammatory activity of B-cells by blocking two proteins — BLyS, a B-cell lymphocyte stimulator, and APRIL, a proliferation-inducing ligand — that play a key role in their development.

Specifically, the experimental therapy was created by fusing a fragment from an antibody protein with a part of the TACI receptor, a protein involved in regulating B-cell development.

The treatment candidate is now being tested in an open-label clinical trial (NCT04302103) that enrolled a total of 29 adults with MG on standard therapy.

Participants were randomly assigned to receive either a low (160 mg) or high (240mg) dose of telitacicept, given as a weekly under-the skin (subcutaneous) injection for 24 weeks, or nearly six months.

The trial’s main goal is to assess telitacicept’s effectiveness in lessening disease severity at the end of the study when compared with the trial’s start (baseline). Efficacy was measured using the Quantitative Myasthenia Gravis (QMG), a measure of MG severity in which higher scores indicate more disability.

The new data showed that patients in the low-dose group had a mean reduction of 7.7 points in QMG, while those receiving a high dose had a mean reduction of 9.6 points.

A reduction of three points is deemed clinically significant, and five points or higher is representative of “significant curative effects,” according to RemeGen.

“As a fully-integrated biopharmaceutical company committed to the discovery, development and commercialization of innovative and differentiated biologics [products made from living organisms or that contain components of living organisms] for the treatment of autoimmune, oncology and ophthalmic diseases, our vision to become a leading player in the global biopharmaceutical industry is rapidly being realized,” Fang said.

Telitacicept also is being investigated as a potential therapy for systemic lupus erythematosus (SLE), another autoimmune disease mediated by B-cells. Data from prior trials showed it could reduce SLE severity.

RemeGen’s pipeline includes more than 10 drug candidates, seven of which are in clinical development, according to Fang.

This therapy recently was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of MG.