Date: 2015-11-02
Type of information: Clinical trial autorization
phase: 2
Announcement: clinical trial authorization
Company: NovImmune (Switzerland)
Product: NI-0101 ( anti-TLR4 ( toll-like receptor-4) monoclonal antibody)
Action
mechanism: monoclonal antibody. NI-0101 is an anti-TLR4 ( toll-like receptor-4) monoclonal antibody. By inhibiting the ability of the subunits of the receptor complex to function together, NI-0101 inhibits TLR4 signaling regardless of the pro-inflammatory signal, making it an attractive drug candidate for a range of applications. Published research has suggested that excessive TLR4 activation may be responsible for the inflammation associated with rheumatoid arthritis.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial details:
Latest
news: * On November 2, 2015, Novimmune announced that it received approvals from the FDA and the U.K. Medicines and Healthcare products Regulatory Agency to begin testing NI-0101, an anti-TLR4 ( toll-like receptor-4) monoclonal antibody, in patients with rheumatoid arthritis. No biomarkers are currently available that can predict treatment response in advance. As a result, patients must endure a trial and error approach to finding the treatment to which they best respond. “With our new drug, NI-0101, Novimmune hopes to enhance treatment effectiveness through the ability to predict response prior to drug administration,” said Novimmune Chief Executive Officer Jack Barbut. “If the results of the new trial confirm our hypothesis, this approach could lead to NI-0101 becoming the first personalized medicine for rheumatoid arthritis sufferers and ultimately delivering a higher response rate than current treatments.”
