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Aprea Therapeutics Completes Full Enrollment of Phase 3 Clinical Trial in TP53 Mutant Myelodysplastic Syndromes (MDS)
Topline data expected by year-end 2020Applications for US and EU regulatory approval planned for 2021 BOSTON, June 03, 2020 (GLOBE NEWSWIRE) -- Aprea
About this update from Aprea Therapeutics, Inc.
[{"type":"text","content":"Topline data expected by year-end 2020Applications for US and EU regulatory approval planned for 2021 BOSTON, June 03, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that patient enrollment in its Phase 3 clinical trial evaluating eprenetapopt with azacitidine for the treatment of front-line TP53 mutant myelodysplastic syndromes (MDS) has been completed. Topline results are expected by year-end 2020. Aprea plans to include the results of the trial in a New Drug Application (NDA) to the U.S. FDA and a Marketing Authorization Application (MAA) to the EMA in 2021.\n “Completion of enrollment in this Phase 3 trial is an important milestone for Aprea and our first-in-class p53 reactivator, eprenetapopt,” said Christian S. Schade, President and Chief Executive Officer of Aprea. “We continue to advance the development of eprenetapopt with the goal of providing an urgently needed therapeutic option to patients with p53 mutated MDS.” The randomized, controlled pivotal Phase 3 trial is designed to evaluate eprenetapopt with azacitidine compared with azacitidine alone as front-line therapy in intermediate, high, and very high risk TP53 mutant MDS patients. The multi-center trial enrolled 154 patients, randomized 1:1 to the two arms with a primary endpoint of CR rate. The trial has 90% power with P-value About Aprea Therapeutics, Inc. Aprea Therapeutics, Inc. is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53. The Company’s lead product candidate is APR-246 (eprenetapopt), a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). APR-246 has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the European Commission for MDS, AML and ovarian cancer. For more information, please visit the company website at www.aprea.com. The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ ...