Aprea announces SRC enhances dosing of patients with ATRN-119 at 800 mg

Aprea Therapeutics announced that the Safety Review Committee, SRC, overseeing the ongoing ABOYA-119 clinical trial has determined that dosing of patients with ATRN-119 at 800 mg once daily can commence and that Cohort 6 is open for enrollment. This decision follows review of the safety and pharmacokinetic data from patients treated at 550 mg once daily. “We are very pleased with the progress in the ABOYA-119 clinical trial and with the SRC’s recent endorsement to commence dosing of patients with ATRN-119 at 800 mg once daily representing progress in ATRN-119 development,” said Nadeem Mirza, M.D., M.P.H., Chief Medical Officer of Aprea. “Pharmacokinetic data show that the duration of systemic exposure substantially increases with each dose level of ATRN-119. New data reported at the recent AACR annual meeting show that plasma concentrations of the drug are entering the expected therapeutic range at dose levels of 550 mg and above. We anticipate to announce additional safety and initial efficacy data from this study in the second half of 2024 and to complete dose escalation by the fourth quarter. Overall, we are very excited by ATRN-119, which we believe is differentiated from other ATR inhibitors in selectivity and toxicity profile.”