Karolinska Development’s portfolio company Aprea Therapeutics completes enrollment in Phase 3 study of eprenetapopt
STOCKHOLM, SWEDEN – June 3, 2020. Karolinska Development AB’s (Nasdaq Stockholm: KDEV) portfolio company Aprea Therapeutics announced today that it has completed enrollment in a Phase 3 clinical trial evaluating eprenetapopt with azacitidine for the treatment of front-line TP53 mutant myelodysplastic syndromes (MDS). 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.
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 < 0.05 to detect a difference in CR rates of 50% in the eprenetapopt-containing arm versus 25% in the azacitidine-only control arm.
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: email@example.com
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About Karolinska Development AB
Karolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying breakthrough medical innovations in the Nordic region that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that advance these assets into commercial products that are designed to make a difference to patients' lives while providing an attractive return on investment to shareholders.
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