|
4SC AG, a drug discovery and development company, announced the dosing of the first patient in its Phase IIb trial evaluating the combination of 4SC’s oral, synthetic, disease-modifying anti-rheumatic drug (DMARD) 4SC-101 (formerly SC12267) and methotrexate (MTX) in mild to moderate rheumatoid arthritis (RA) patients.
4SC-101 will be investigated in RA patients in the “COMPONENT” study entitled “A Randomized, Double Blind, Placebo-Controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis”. This study will primarily evaluate the efficacy of the combination of 4SC-101 and MTX in RA patients, compared to methotrexate alone. The trial will comprise 244 patients in two study arms of 122 patients each. The first arm will receive 4SC-101 (35 mg) plus MTX, while the other group will receive placebo plus MTX. 4SC 101 and MTX will be administered orally for a total study duration of 13 weeks per patient. Patients eligible for the study must have active RA and have received weekly doses of MTX (10 25 mg/week) for a minimum of 3 months prior to Day 1 dosing and have received a stable MTX dose of 10–25 mg/week for at least 6 weeks prior to Day 1 dosing.
The primary endpoint of the study is ACR20, a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician’s global assessment of disease, patient’s global assessment of disease, patient’s assessment of pain, C reactive protein or erythrocyte sedimentation rate, and degree of physical disability in Health Assessment Questionnaire (HAQ) score. ACR50, ACR70, DAS28, safety parameters and pharmacokinetics will also be evaluated as secondary endpoints. The study will be performed at 15 rheumatology-experienced trial centres in Poland, Romania, Bulgaria and the Czech Republic. 4SC expects completion of enrolment towards the end of 2010.
Dr Ulrich Dauer, Chief Executive Officer of 4SC commented: “We strongly believe that 4SC-101 has the potential to become the second-line, synthetic DMARD of choice for RA patients responding insufficiently to MTX therapy alone, whilst offering a favourable safety and tolerability profile. Our expectation is based upon promising data generated in a pre-clinical RA model using the combination of 4SC-101 and MTX, and on results obtained in an earlier Phase IIa study using 4SC-101 as mono-therapy treatment in RA patients. I am delighted that 4SC continues to achieve corporate milestones in a timely manner to advance important therapies for patients in need of new treatment options.”
More information about both trials can be found on www.clinicaltrials.gov.
|
Source: Press Release 4SC AG
|
