Trogarzo: which risks did reviewers probe?

“However, throughout the study, antibodies against ibalizumab were observed in 83% (10/12) and 58% (7/12) of the animals at the low and high dose (25 and 50 mg/kg), respectively.”

“distribution (47-52 ml/kg), approximately the plasma volume of the monkeys, suggesting that the drug was largely restricted to the vasculature.”

“Based on animal data, ibalizumab-uiyk use during pregnancy may cause reversible immunosuppression (CD4+ T cell and B cell lymphocytopenia) in infants exposed to ibalizumab-uiyk in utero.”

“However, throughout the study, antibodies against ibalizumab were observed in 83% (10/12) and 58% (7/12) of the animals at the low and high dose (25 and 50 mg/kg), respectively. In total, 7 animals at the low dose and 1 animal at the high dose developed a severe anti-drug-antibody response, resulting in lack of exposure, after which these animals were euthanized and necropsied around 6.5 months.”

“One sample tested positive with low titer anti-ibalizumab antibodies. No adverse reaction or reduced efficacy was attributed to the positive sample reported in this subject.”