RuiYi, Inc., a biopharmaceutical company focused on discovering and developing novel antibody-based therapeutics, recently announced it has dosed the first human subject in the study of lead product candidate, Gerilimzumab, a promising monoclonal antibody that specifically targets the IL-6 cytokine to treat autoimmune conditions, such as rheumatoid arthritis.
In previously completed preclinical studies, the drug demonstrated an impressive profile, with researchers noting its superior subcutaneous bioavailability, potency and blood half-life compared to other cytokine class biologic RA treatments. These drug characteristics could spell a much less frequent, small volume, subcutaneous, cost-efficient treatment for RA patients in the near future.
The study is designed to be double-blind and placebo-controlled enrolling only healthy participants who will be randomized to receive either single or multiple ascending doses of Gerilimzumab. RuiYi expects the study’s findings to be available within the first quarter of 2016.
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.”
The drug was originally born out of a collaborative partnership between RuiYi and arGEN-X, and eventually, China-based Genor Biopharma. It was in 2012 when RuiYi licensed the drug from arGEN-X, and obtained worldwide rights to Gerilimzumab. The following year, a partnership was signed between RuiYi and Genor over Gerilimzumab’s development and commercialization. In fulfilment of the contract, Genor provided the former with IND enablement and manufacturing support.
“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.”
RuiYi believes in the untapped potential of harnessing IL-6 inhibitors to treat RA patients, and is confident it has something substantial to bring to a saturated RA and autoimmune disease market that is now estimated to be worth $35 billion globally.