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The Radboudumc and Philikos B.V., a Dutch biotechnology company developing antibody-based therapies to treat severe immune disorders, enrolled the first patient in a Phase 1/2 clinical study. The study will evaluate the use of T-Guard for the treatment of patients with diffuse cutaneous systemic sclerosis (dcSSc), a serious autoimmune disorder with limited treatment options. The study is planned to enroll 12 adult patients who have been diagnosed within the last three years with dcSSc and whose disease remains refractory despite prior systemic immunosuppressive therapy.
“With no widely accessible and safe disease-modifying treatments available, there is a high unmet medical need for effective new therapies for systemic sclerosis,” said Principal Investigator Madelon Vonk, M.D., Ph.D., Associate Professor Systemic Sclerosis at Radboudumc. “T-Guard, with promising preclinical data and initial clinical results, has the potential to significantly impact patients suffering from this debilitating and life-threatening autoimmune disease characterized by inflammation and fibrosis.”
The study will begin with four patients, after which an independent Data Safety Monitoring Board (DSMB) will assess safety and preliminary efficacy. If the balance between adverse effects and efficacy is positive, the study will be expanded to include a total of 12 participants. Interim data and the recommendation of the DSMB are expected by the end of 2025.
Systemic sclerosis
Systemic sclerosis (also known as scleroderma) is an autoimmune disease in which the immune system turns against one's own body. In systemic sclerosis, it is mainly “overactive” T cells and NK (natural killer) cells that cause chronic inflammation in connective tissue. This leads to hardening of the skin and damage to many other organs.
Read the complete press release on Philikos's website.
More about our collaboration with Philikos hier.
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