The U.S. Food and Drug Administration (FDA) has agreed to allow Kyverna Therapeutics to begin clinical testing of KYV-101, the company’s investigational cell therapy for lupus nephritis, a form of lupus that causes kidney damage. Kyverna submitted a request, in the form of an investigational new drug…
Kyverna Therapeutics has submitted an investigational new drug (IND) application asking regulators for permission to begin clinical testing on KYV-101, an experimental cell therapy for lupus nephritis — a severe manifestation of lupus that causes kidney damage. The company is actively working with sites in the U.S. and…
The first participant has been dosed in a pivotal Phase 2/3 trial testing Biogen’s anti-inflammatory medication litifilimab (BIIB059) in people with cutaneous lupus erythematosus (CLE), the company announced. The study, called AMETHYST (NCT05531565), is recruiting adults with CLE, whose disease is active despite standard antimalarial treatment, at…
Telitacicept, a B-cell-targeting therapy developed by RemeGen, outperformed a placebo at reducing the severity of systemic lupus erythematosus (SLE) in a Phase 3 clinical trial in China, the company announced. “We are delighted with the news of the preliminary results of the Phase III confirmatory study of our proprietary…
The European Commission has approved Lupkynis (voclosporin) to treat active lupus nephritis, a serious complication of systemic lupus erythematosus (SLE) that is characterized by kidney inflammation. The approval is valid in all European Union (EU) member states, as well as Iceland, Liechtenstein, Norway, and Northern Ireland. Lupkynis received a similar…
DxTerity Diagnostics’ interferon-1 gene signature test, which can be used to help guide treatment decisions for people with systemic lupus erythematosus (SLE), is now available for use in all 50 U.S. states, the company has announced. “It is our mission to transform patient care with precision diagnostic tools that…
Active lupus nephritis — kidney inflammation as a result of lupus — is associated with a much higher risk of pregnancy complications, such as fetal loss and preeclampsia, according to a new analysis. The study also showed pregnancy complications are more common in Black women with lupus than among…
The Lupus Foundation of America and Lupus Canada are funding a new study to better understand the role of platelets in lupus. The Lupus Canada Catalyst Award, a one-year grant to fund research for a scientist in Canada studying the autoimmune disease, was awarded to Éric Boilard,…
The Lupus Research Alliance (LRA) has announced $9 million in grants — three awards each totaling $3 million — to fund new research projects that aim to better understand lupus and pave the way toward the development of better treatment strategies for the inflammatory autoimmune disease. The funding is…
Alpine Immune Sciences and Evotec announced the expansion of an agreement to manufacture ALPN-303, an experimental anti-inflammatory therapy that Alpine is developing for systemic lupus erythematosus (SLE) and other diseases driven by immune B-cells. Under the initial 2020 agreement, Evotec’s subsidiary Just-Evotec Biologics used its continuous manufacturing…