Rheumatoid arthritis clinical trial to continue
Drug formulation PRTX-100 passed a scheduled interim data safety monitoring committee meeting.
A clinical trial into a treatment for patients with rheumatoid arthritis is to continue its progress following a monitoring review.
Protalex announced the PRTX-100 Phase 1b trial in patients with active rheumatoid arthritis will resume enrolment and dosing after a planned interim safety review.
The clinical trial is a randomized, multiple-dose, dose-escalation study into PRTX-100's safety and tolerability alongside existing treatments methotrexate and leflunomide for adult patients.
This phase is expected to enroll up to 40 patients in four groups, with staged dosing from 1.5mg/kg to 18.0mg/kg, alongside a placebo.
Protalex also confirmed it has entered into a contract with a European producer to develop the drug formulation at higher doses.
Rheumatoid arthritis is an auto-immune disease that affects cartilage and bone around the joints. It is chronic, progressive and debilitating and affects around 580,000 in England alone.
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