US-based biotechnology firm RuiYi has dosed the first patient in a double-blinded and placebo controlled trial of Gerilimzumab, a new monoclonal antibody, to treat rheumatoid arthritis (RA) and other autoimmune disorders.
Gerilimzumab is directed against the IL-6 cytokine and the trial includes healthy volunteers in both single and multiple ascending dose cohorts.
The company noted that the drug has a compelling product profile, showing the highest combined subcutaneous bioavailability, potency and blood half-life amongst the cytokine class of biologic treatments for RA in preclinical studies.
The company intends to report the trial’s results in the first quarter of next year and advance Gerilimzumab into further studies, including in moderate to severe RA.
The drug has been developed as part of a collaboration which involves RuiYi, arGEN-X and Genor Biopharma of China.
RuiYi CEO Paul Grayson said: "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 recognised 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."
In late 2012, RuiYi in-licenced the global rights to Gerilimzumab from arGEN-X, a biopharmaceutical firm.
In 2013, RuiYi partnered with Genor Biopharma to develop and commercialise Gerilimzumab in China.
Under that deal, Genor provided IND enablement and manufacturing process development to support rest of world development, where RuiYi has retained all commercial rights.
In addition to Gerilimzumab, RuiYi is advancing RYI-018, a first in class anti-CB1 inverse agonist to treat fibrotic and metabolic diseases, including nonalcoholic steatohepatitis.