Sjögren’s Syndrome Therapeutics - Clinical Trials, Designation and Developments

The study analyzed that Sjögren’s syndrome pipeline comprises of approximately 42 drug candidates in different stages of development. Sjögren’s syndrome is a chronic inflammatory disease, which leads to infiltration of lacrimal and salivary glands. It is mostly associated with sicca symptoms, which include dry eyes (xeropthalmia) and dry mouth (xerostomia). It is also associated with other autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis. The treatment approaches for this disease mostly include monoclonal antibodies and small molecules, which are being developed to target and reduce the inflammatory mediators. Clinical presentation can vary considerably from relatively mild sicca symptoms, fatigue and arthralgia to severe systemic symptoms such as glomerulonephritis, vasculitis and a host of neurological manifestations.

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The positive results of the drug candidates are speeding up the drug development process for Sjögren’s syndrome. In August 2016, Aldeyra Therapeutics, Inc. presented the positive Phase II results of NS2, a 1% dermatologic cream under Phase II stage of development for Sjögren's syndrome. Six of six (100%) subjects treated with NS2 improved over the course of therapy as assessed by central review, and the improvement was greater than that observed among vehicle-treated patients (p < 0.05).

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Some of the key players developing drugs for Sjögren’s syndrome include Kissei Pharmaceutical Co., Ltd., UCB Group, Bristol-Myers Squibb Company and others.