Immune Regulation Ltd, a US and UK based clinical stage biotechnology company, announced that it has received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for a new patent covering IRL201805 (‘1805). ‘1805 is a first-in-class compound derived from the endogenous immuno-regulatory protein Binding Immunoglobulin Protein (BiP) and is in development to treat rheumatoid arthritis and other inflammatory and autoimmune diseases. The new patent provides Immune Regulation with additional intellectual property protection covering the composition of matter of ‘1805.
“This new ‘1805 patent significantly strengthens Immune Regulation’s intellectual property portfolio,” said Jonathan Rigby, Group CEO of Immune Regulation. “We will continue to prosecute patent applications for both of our first-in-class immune resetting drug candidates ‘1805 and ‘1104.”
Previously reported data from a Phase 1/2A dose range finding study in patients with active rheumatoid arthritis who had failed one or more standard therapies, ‘1805 given intravenously as a single dose, showed a good tolerability profile, with no drug-related toxicities. Clinical responses and remissions of disease was achieved in some patients, which correlated to early reductions in a number of inflammatory biomarkers, in those patients that had been given ‘1805. The activity of ‘1805 appeared to be long lasting, with effects on biomarkers and clinical changes still evident at the cessation of the 12-week clinical trial. The clinical responses were associated with an induction of Treg cells. This study represents early proof of concept for ‘1805 as a safe and effective immunomodulating treatment for rheumatoid arthritis.
A Phase 2 clinical study with ‘1805 is currently being planned in adult patients with moderate to severe rheumatoid arthritis to further assess remission rates and longevity of action.