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Curis Initiates Phase 2 LUCAS Study Of CA-4948 For Treatment Of Anemia

Curis Inc. (CRIS) said Tuesday that it has initiated a phase 2 investigator-sponsored trial. The trial will evaluate CA-4948, a novel, small molecule IRAK4 kinase inhibitor, for the treatment of anemia in patients with very low, low, or intermediate-risk myelodysplastic syndromes or MDS.

The phase 2 study is sponsored by investigators at Universität Leipzig in Germany.

"Following the very promising preliminary data we presented in December in patients with relapsed/refractory AML and high-risk MDS, we are eager to further explore if CA-4948 may also provide benefit in other indications, including in MDS patients with lower risk profiles," said James Dentzer, President and Chief Executive Officer of Curis.

The trial is expected to start recruitment in the second quarter of 2021 at 17 sites of the D-MDS and is designed to enroll 84 patients across two cohorts consisting of 42 patients each. Cohort A will include erythropoiesis stimulating agent (ESA) refractory/intolerant patients and Cohort B will include ESA naïve patients with transfusion dependence (min. 20 patients) or transfusion independence (min. 20 patients).

The company noted that patients in both cohorts will receive 300mg CA-4948 twice-daily (BID) for 21 days in at least four repeating cycles lasting 28 days each. The primary endpoint of the study is to evaluate the proportion of patients that develop an erythroid response (HI-E) according to IWG 2018 criteria.

Secondary and exploratory endpoints of the study include: broader anti-cancer activity, safety & toxicity, and predictive biomarkers. An interim analysis for futility will be conducted after 21 patients have completed the designated treatment period in either cohort.

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