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Aprea (APRE) Plunges as Late-Stage MDS Study Fails to Meet Goal
Shares of clinical-stage biopharmaceutical company, Aprea Therapeutics, Inc (APRE - Free Report) , plummeted 78% after it announced that the late-stage study evaluating the safety and efficacy of lead candidate, eprenetapopt, combined with azacitidine (AZA) versus AZA alone in TP53 mutant myelodysplastic syndromes (MDS) failed to meet the primary endpoint.
The phase III study enrolled 154 MDS patients, randomized 1:1 to either the eprenetapopt with AZA arm or the AZA alone arm.
The study did not meet the predefined primary endpoint of complete remission (CR) rate.
The analysis of the primary endpoint at this data cut demonstrated a higher CR rate in the experimental arm receiving eprenetapopt with AZA as compared to the control arm receiving AZA alone but did not reach statistical significance. In the intention-to-treat population of 154 patients, the CR rate in the eprenetapopt with AZA arm was 33.3% compared to 22.4% in the AZA alone arm.
We note that eprenetapopt is a small molecule p53 reactivator that is in late-stage clinical development for hematologic malignancies, including MDS and acute myeloid leukemia (AML). Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS. It has also received Fast Track designation from the FDA for AML, and Orphan Drug designation from the European Commission for MDS, AML and ovarian cancer.
Shares of Aprea have slumped 88.6% in the year so far compared with the industry’s growth of 7.6%.
Companies like Roche (RHHBY - Free Report) , Novartis (NVS - Free Report) and Amgen (AMGN - Free Report) are also developing small molecule inhibitors that are designed to target the p53-MDM2 interaction.
Aprea currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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