Date: 2012-01-25
Type of information:
phase: formulation study
Announcement:
Company: MediGene (Germany)
Product: RhuDex®
Action mechanism: RhuDex® as an oral, disease-modifying drug for the treatment of autoimmune diseases, such as rheumatoid arthritis. RhuDex® is a CD80 antagonist that blocks the undesired activation and proliferation of T cells and thus has an immunomodulating and anti-inflammatory effect. This drug candidate can be classified with the group of \"Disease-Modifying Antirheumatic Drugs\" (DMARDs). In a phase IIa trial in 29 patients, RhuDex® demonstrated indications of biological activity relevant for the treatment of rheumatoid arthritis.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial
details: During the formulation study, a single dose of RhuDex® will be administered orally to up to twelve volunteers. Based on the innovative RapidFACT (Rapid Formulation Development and Clinical Testing) study design, variants of formulations can be tested over a short period because the trial medication is produced immediately prior to dosing. This approach facilitates a fast and cost-efficient execution of the trial.
Latest
news: MediGene announced that it continues clinical development of its drug candidate RhuDex® by initiating a clinical formulation study. The trial objective is to develop an optimized oral formulation of the active substance suitable for the treatment of chronic diseases.
The results of this formulation study are expected midyear 2012.
Previous preliminary formulations of RhuDex® permitted initial clinical trials of the drug candidate. For the long-term development and subsequent marketability of the product, MediGene seeks an improved oral formulation and dosage form of RhuDex® to facilitate a therapeutically ideal release of the active ingredient, as well as a patient-friendly dosing regimen.
