LA JOLLA, Calif., Jan. 3, 2017 /PRNewswire/ -- Bird Rock Bio, Inc., a clinical stage biopharmaceutical company, announced today that it had received approval for the initiation of a 200 patient, Phase 2 rheumatoid arthritis (RA) clinical trial for gerilimzumab, a novel therapeutic antibody to the IL-6 cytokine, to be conducted solely in Brazil. Working closely with leading rheumatologists, Techtrials International, CONEP, and ANVISA, Bird Rock Bio designed a clinical protocol specifically to address the patient population in Brazil. The trial is designed to evaluate three dose regiments; 1) a 20 mg subcutaneous (SC) loading dose followed by a 10 mg maintenance dose after 8 weeks, or 2) a 10 mg SC loading dose followed by a 5 mg maintenance dose after 8 weeks, or 3) a low 5 mg SC loading dose followed by a 2 mg maintenance dose after 8 weeks, all in combination with methotrexate, compared to methotrexate control.
"A challenge of developing novel therapeutics in markets such as the U.S., where the therapeutic landscape is more mature and most patients are already being treated with the first, second or even third biologic, is that the standard of care is not as relevant and the patient population of interest is not as available," said Paul Grayson, CEO of Bird Rock Bio. "The largest medical need in RA outside the U.S. is still affordable access; however, a therapeutic with low, infrequent dosing and low cost of goods such as gerilimzumab, also requires a creative clinical development strategy. Working with global leaders in RA, along with the top rheumatologist in Brazil, and Techtrials International, the leading Brazilian CRO, we were able to design a thoughtful clinical protocol to address the needs of the patient, ethics committees, and regulatory agencies of Brazil."