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 trial 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 (PI) Madelon Vonk, M.D., Ph.D., Associate Professor Systemic Sclerosis at Radboud University Medical Center (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.
Biotech Booster program
Philikos B.V. joined the Biotech Booster program earlier this year as a proof-of-principle project at the Radboud UMC. The program provides the network, financial support and guidance that is needed to help bring their solution to patients faster. This clinical trial study is an important step in their path to translating scientific discovery to societal application.
Read their full press release here.
Image: Philikos B.V.
