April was awareness month for Sjogren’s syndrome. This systemic autoimmune disease leads to dry eyes and mouth and, in more severe cases, a variety of other
disease states, such as profound fatigue, chronic pain, central organ involvement, neuropathies and lymphomas. While much work remains to be done to treat the disorder comprehensively, there is hope as several Phase III trials for systemic treatments are underway or close to being launched.
Currently, therapies such as Xiidra exist to address localized symptoms such as dry eye disease, but there are no FDA-approved systemic treatments for Sjogren’s syndrome. Previous attempts to treat the disease systemically have failed. In March 2020, Bristol-Myers Squibb’s Phase III ASAP-III trial data showed that Orencia (abatacept) had no significant clinical effect compared to the placebo. The program appears to have been dropped.
But this past January, Horizon Therapeutics announced better news. Its systemic treatment for Sjogren’s, dazodalibep,
met the primary endpoint in a Phase II trial for two separate groups of Sjogren’s patients, those with moderate-to-high systemic disease activity and those with moderate-to-severe symptoms.
Acting as an intravenous drug that blocks the T cell interactions with CD40-expressing B cells characteristic of Sjorgren’s, dazodalibep is also in Phase II trials for focal segmental glomerulosclerosis, the scarring of kidney tissue caused by autoimmune disease. While the Phase II data in Sjogren’s syndrome has yet to be documented and released in medical literature, Horizon is currently planning for Phase III, suggesting that the company is hopeful the trials will proceed with a definitive timeline.
Meanwhile, Novartis is recruiting patients for its Phase III trials of ianalumab, a systemic treatment for Sjogren’s. As a monoclonal antibody, ianalumab is administered subcutaneously to suppress B cells. In the 2018
Phase IIb trial, patients were split into cohorts based on four different dosing regimens, and those on the highest dose experienced better treatment outcomes than their placebo comparators. The data reaffirm that ianalumab is safe and effective, with improvements seen in those who transitioned onto the drug from placebo and declines seen in those who transitioned off the drug to placebo.
Finally, RemeGen is preparing for Phase III trials of telitacicept in Sjogren’s syndrome in China. As a subcutaneous treatment, telitacicept inhibits the lymphocyte stimulator and the A proliferation-inducing ligand. It is approved in China to treat another autoimmune disorder, systemic lupus erythematosus, and is also undergoing investigation in the U.S. for this and still other autoimmune diseases.
