FDA orders clinical hold on Aprea's p53 reactivator as struggling biotech pledges to address safety concerns
Little Aprea Therapeutics just tripped yet again on its rocky path to develop a drug that can reactivate the mutant tumor suppressor protein p53.
The Boston-based biotech said the FDA has placed a partial clinical hold on its trials of eprenetapopt, where the drug is combined with the chemo azacitidine as an experimental treatment for multiple myeloid malignancies.
While Aprea didn’t specify the reason for the hold or what exact questions the agency is asking, CEO Christian Schade hinted in a statement it has to do with toxicity concerns.
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