After a ‘breakthrough’ beginning to 2020, little Aprea gets crushed by a PhIII failure
Boston-based biotech Aprea Therapeutics $APRE started the year with a promising breakthrough therapy designation from the FDA for its lead p53 reactivating program for eprenetapopt. And it’s ending the year with a Phase III failure for the drug.
Aprea reported out Monday morning that the drug combined with azacitidine failed to significantly outperform azacitidine alone in TP53 mutant myelodysplastic syndromes. And their stock price crumbled under the rout that followed, dropping 73%.
Aprea’s pipeline consists of this one drug in multiple indications.
The combo approach hit a combined complete response rate of 33% compared to 22.4% for the solo approach, but that only qualified for a p value of 0.13.
Eyal Attar, the CMO at Aprea, noted:
We will continue to analyze data as it matures and follow patients who are still receiving study treatment. Our other clinical trials continue to progress and we remain committed to pursuing our clinical development programs.