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Bird Rock Bio to initiate gerilimzumab trial in Brazil
Bird Rock Bio Inc. received approval from ANVISA and CONEP for the initiation of a 200-patient, phase 2 clinical trial in Brazil for gerilimzumab, an interleukin-6 cytokine antibody for the treatment of rheumatoid arthritis, according to a press release. This is the first inpatient trial with the novel therapeutic antibody to take place solely in Brazil, the release noted.
“A challenge of developing novel therapeutics in markets such as the [United States] U.S., where the therapeutic landscape is more mature and most patient 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,” Paul Grayson, chief executive officer (CEO) of Bird Rock Bio, said in the release. “The largest medical need in [rheumatoid arthritis] 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.”
The trial, which will be co-designed by Techtrials International, CONEP, ANVISA and Bird Rock Bio, will evaluate three dose regimens: 20-mg subcutaneous for 8 weeks followed by 10-mg maintenance; 10-mg subcutaneous for 8 weeks followed by 5-mg maintenance; and 5-mg subcutaneous for 8 weeks followed by 2-mg maintenance. Each regimen will be taken in combination with methotrexate and will be compared with a methotrexate control group, according to the release.
“This is an exciting time to be conducting trials in Brazil,” Douglas Valverde, CEO of Techtrials, said in the release. He added, “We are excited to work with the 25 sites identified in Brazil to conduct this ‘first-of-a-kind’ clinical program.”
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