22 hours Ago By Republished By Echobase.ai
The trial will recruit individuals with active, moderate-to-severe Sjögren’s disease. Credit: PeopleImages.com – Yuri A / Shutterstock.
US-based biopharmaceutical company Cullinan Therapeutics is due to begin a domestic trial of its drug candidate CLN-978 for treating Sjögren’s disease (SjD).The trial will recruit individuals in the US with active, moderate-to-severe SjD who meet the 2016 American College of Rheumatology (ACR) or European Alliance of Associations for Rheumatology (EULAR) classification criteria and test positive for anti-Sjögren’s-syndrome-related antigen A (SSA/RO) antibodies and/or rheumatoid factor.Its primary goal is to assess CLN-978’s tolerability and safety in these subjects while its secondary objectives include evaluating the drug’s pharmacodynamics, immunogenicity, impact on disease activity, and pharmacokinetics.
Cullinan Therapeutics expects to begin the trial this quarter, having received US Food and Drug Administration (FDA) clearance to study the therapy in systemic lupus erythematosus (SLE) and European Medicines Agency (EMA) approval for its use in active, difficult-to-treat rheumatoid arthritis.Cullinan Therapeutics’ chief medical officer Jeffrey Jones said: “We are pleased to rapidly progress our global clinical development programme for CLN-978, now open for patients living with systemic lupus erythematosus, rheumatoid arthritis, and soon, SjD.“We are grateful to the investigators in our SLE trial who have been enthusiastic partners in our research, and we look forward to opening this new trial to patients with SjD in the US.
”CLN-978 is concurrently being investigated in SLE subjects across Australia, Europe and the US, and in rheumatoid arthritis patients at several European sites.The drug is a bispecific Cluster of Differentiation 19 (CD19) T-cell engager with a molecular size of 65 kilodaltons (kDa).It is designed for high-affinity CD19 binding to target B cells, including those with very low levels of CD19.
An internal team at Cullinan Therapeutics developed the therapy, which the company said has the potential to be a ready-to-use, subcutaneous treatment option for autoimmune conditions such as SLE, SjD and rheumatoid arthritis. Sign up for our daily news round-up!Give your business an edge with our leading industry insights. SEO Powered Content & PR Distribution.
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Source: https://www.clinicaltrialsarena.com/news/cullinan-cln-978/.
