Aprea Therapeutics Inc. (NASDAQ: APRE) stock was absolutely crushed to start out the week after the company announced results from its late-stage trial evaluating the safety and efficacy of its treatment for myelodysplastic syndromes (MDS).
MDS are not well known and affect less than 200,000 Americans per year. They are regularly unrecognized, underdiagnosed rare bone marrow failure disorders that can form blood cancer or leukemia.
Specifically, the data come from the Phase 3 clinical trial evaluating the safety and efficacy of eprenetapopt with azacitidine (AZA) versus AZA alone in TP53 mutant MDS. However, the trial did not meet the predefined primary endpoint of complete remission rate.
Analysis of the primary endpoint at this data demonstrated a higher complete remission rate in the experimental arm receiving eprenetapopt with AZA versus the control arm receiving AZA alone, but did not reach statistical significance.
While analysis of certain secondary endpoints (namely, objective response rate and duration of responses) appears to favor the experimental arm at this data cut, they were not significantly different.
Management noted that although it was disappointed the topline results did not reach statistical significance, it continues to believe that eprenetapopt can offer clinical benefit to patients with TP53 mutant malignancies. The company will continue to analyze data from this study, and it expects to present this at a future scientific conference.
Even excluding Monday’s move, Aprea Therapeutics had underperformed the broad markets with a decline of about 45% year to date. In the past six months alone, the stock was down closer to 35%.
Aprea Therapeutics stock traded down about 76% on Monday to $5.99, in a 52-week range of $5.35 to $53.11. The consensus price target is $36.17.