Opinion: Hope on the Horizon for Sjogren’s Syndrome
BIOMARKER
1. April was awareness month for Sjogren's syndrome, a systemic autoimmune disease with symptoms including dry eyes, dry mouth, fatigue, and chronic pain.
2. There are no FDA-approved systemic treatments for Sjogren's syndrome, with previous attempts failing, such as Bristol-Myers Squibb's Orencia.
3. Horizon Therapeutics announced positive Phase II trial results for dazodalibep, a systemic treatment for Sjogren's syndrome.
4. Dazodalibep works by blocking T cell interactions with CD40-expressing B cells and is also being tested for focal segmental glomerulosclerosis.
5. Novartis is recruiting patients for Phase III trials of ianalumab, another systemic treatment for Sjogren's syndrome, which showed promising results in Phase IIb trials.
6. RemeGen is preparing for Phase III trials of telitacicept in Sjogren's syndrome in China, which is already approved for treating systemic lupus erythematosus.
7. Telitacicept inhibits the lymphocyte stimulator and the A proliferation-inducing ligand and is being investigated for other autoimmune diseases in the U.S.
8. RemeGen's Phase II trial for Sjogren's syndrome showed significant results, but the company has not disclosed detailed data or safety information.
9. There are currently 18 systemic treatments for Sjogren's syndrome under investigation, with eight in Phase I and 10 in Phase II trials.
10. If successful, systemic treatments for Sjogren's syndrome may hit the U.S. market in the latter half of this decade.