Theraclone Sciences, Inc., a therapeutic antibody discovery and development company, today announced positive top-line data from its Phase 1 trial of TCN-032, a broadly protective, fully human monoclonal antibody, being developed for the treatment of influenza A infections. TCN-032 was well tolerated throughout the study, with no dose-limiting toxicities or serious adverse events observed, and demonstrated a favorable immunogenicity profile.
"TCN-032 is a therapeutic antibody drug candidate discovered with our I-STARTM platform, and we are extremely pleased with the safety and pharmacokinetic profile and lack of immunogenicity generated from its Phase 1 trial," commented Eleanor Ramos, M.D., Chief Medical Officer, Theraclone Sciences. "Based on these data, we are confident moving forward to the next step in the development of TCN-032, a Phase 2 influenza viral challenge trial to be conducted in human subjects."
The randomized, double-blind, placebo-controlled Phase 1 study enrolled 40 healthy adult volunteers in 5 single-dose cohorts of TCN-032, escalating from 1 mg/kg to 40 mg/kg. TCN-032 showed pharmacokinetic parameters consistent with a human antibody. No antibodies against TCN-032 were detected. The detailed results from this trial will be presented at an upcoming scientific conference.
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