Kyntra Bio (KYNB), a biopharmaceutical company, on Thursday released new data from the Phase 3 MATTERHORN trial for Roxadustat in treating anemia associated with lower-risk myelodysplastic syndrome.
Myelodysplastic syndromes (MDS) are characterized by dysfunctional progenitor blood cells and stem cells, causing chronic anemia. About 80% of MDS patients have anemia at the time of diagnosis, and 50% require regular blood transfusions. About 77% of patients are considered lower-risk MDS (MDS) due to the low incidence of the disease.
Roxadustat is an oral medication developed to increase endogenous production of the erythropoietin protein, which promotes erythropoiesis, improved iron absorption and mobilization. The drug has been approved in China, Europe, and Japan for the treatment of anemia in patients of chronic kidney disease (CKD).
The Phase 3 MATTERHORN trial enrolled 140 patients with LR-MDS and a high transfusion burden (HTB), showing both ring sideroblast positive (RS+) and negative (RS-) disease.
Results indicated that 48% of patients on roxadustat achieved transfusion-independence (TI), compared to only 33% in the placebo group. Post hoc analysis demonstrated that both RS+ and RS- patients showed similar TI rates with treatment.
Over 28 weeks, 48% of the 84 RS- patients dosed with roxadustat were transfusion independent for at least 8 weeks, compared to 28% in the placebo group. A subgroup of patients with HTB also achieved clinically meaningful efficacy, with a significant reduction in the number of red blood cell-plasma transfusions required.
According to the company, the design of a pivotal Phase 3 trial in the U.S. for Roxadustat in treating anemia associated with LR-MDS is being finalized. Depending on feedback from the FDA, the study may be initiated in the second half of this year.
KYNB is currently trading at $7.04, up 4.14%
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