RuiYi Announces the First Human Dosing of a Novel Antibody, Gerilimzumab, for the Treatment of Rheumatoid Arthritis and other Autoimmune Disorders
A novel, best in class anti-IL-6 antibody with differentiated pharmacoeconomic potential for both major and key emerging markets
LA JOLLA, California, Sept. 22, 2015 /PRNewswire/ -- RuiYi, Inc. today announced the first human dosing of Gerilimzumab, a novel monoclonal antibody that is directed against the IL-6 cytokine, for the treatment of autoimmune disorders, including rheumatoid arthritis ("RA"). Gerilimzumab has a compelling product profile, demonstrating the highest combined subcutaneous bioavailability, potency and blood half-life amongst the cytokine class of biologic treatments for RA in preclinical studies. These features are anticipated to enable monthly or even less frequent, small volume, subcutaneous dosing and a very low cost of goods.
The trial is double-blinded and placebo controlled, in healthy volunteers, with both single and multiple ascending dose cohorts. The results of the trial are expected to be available in Q1 2016 and support advancing Gerilimzumab into a number of trials, including in moderate to severe rheumatoid arthritis.
RuiYi's CEO, Paul Grayson, commented, "More than 20 million individuals worldwide are afflicted with autoimmune disorders, including RA. One of the greatest unmet medical needs of our time is a cost-effective treatment for these patients, 80% of whom are in emerging markets. We recognized early on that the pharmacologic profile of Gerilimzumab had exceptional pharmacoeconomic potential for patients in both major as well as emerging markets. Gerilimzumab, a potential best in class novel therapeutic with the lowest anticipated pricing of any biologic for RA and with enhanced convenience, should present a valuable treatment option for physicians, patients, and payers worldwide."
Gerilimzumab is the result of a unique collaborative model, involving RuiYi Inc., arGEN-X (Euronext Brussels: ARGX), and Genor Biopharma of China. In late 2012, RuiYi in-licensed the worldwide rights to Gerilimzumab from arGEN-X, a biopharmaceutical company focused on creating and developing differentiated antibodies for the treatment of cancer and severe autoimmune diseases. Early in 2013, RuiYi partnered Gerilimzumab with Genor Biopharma, one of China's leading biopharmaceutical companies, for development and commercialization in China. As part of this agreement, Genor has provided IND enablement and manufacturing process development to support rest of world development, where RuiYi has retained all commercial rights.
"The first human dosing of Gerilimzumab marks significant progress for this exciting antibody product candidate," said Tim Van Hauwermeiren, CEO at arGEN-X. "RuiYi has been an excellent partner for arGEN-X and we've been impressed with how they have efficiently progressed Gerilimzumab, discovered with arGEN-X's SIMPLE Antibody™ platform and utilizing the NHance® half-life extension technology, into clinical studies."
"Gerilimzumab is a very innovative antibody," said Joe Zhou, President and CEO of Genor Biopharma. "It targets a safe and validated pathway and has pharmacologic properties that allow tremendous potential for affordability. We are excited about this important step in the development of Gerilimzumab."
IL-6 inhibitors are a highly promising and validated class of treatments for RA patients. RuiYi believes Gerilimzumab has the potential to play a significant role in the $35 billion global biologic market for RA and other autoimmune diseases by not only treating the large number of anti-TNF refractory patients but also becoming a first-line treatment for moderate and severe patients. RuiYi looks forward to examining how Gerilimzumab can become a compelling treatment alternative for patients with RA and a broad range of serious autoimmune conditions.
About RuiYi, Inc.
RuiYi is focused on the discovery and development of novel antibody therapeutics with upsized potential that represent (1) first in class antibody therapeutics to GPCR targets validated with small molecules yet never successfully drugged and (2) best in class antibody therapeutics to validated targets for unique markets with significant medical need. In addition to Gerilimzumab, RuiYi is advancing RYI-018, a first in class anti-CB1 inverse agonist for the treatment of fibrotic and metabolic diseases, including nonalcoholic steatohepatitis (NASH). RuiYi discovered RYI-018 from its internal discovery efforts utilizing iCAPS (intramembranous Conformation Antigen Presenting System), the Company's proprietary discovery platform. iCAPS has been unique in the discovery of functional antibody therapeutics to G protein-coupled receptors (GPCRs). RuiYi's is based in La Jolla, California. For more, visit www.ruiyibio.com.
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