Clinical Trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER 050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)

MOA: Elritercept is a recombinant fusion protein designed to inhibit signaling by select TGF-β superfamily ligands, including activin A, activin B, GDF8, and GDF11.

Key Eligibility

• Diagnosis of MDS with or without RS according to WHO 2016 classification that
  meets the IPSS-R classification of very low-, low-, or intermediate-risk MDS
• Transfusion dependent (16 weeks pre-randomization)
  a) LTB: 4–7 RBC units / 16 weeks
  b) HTB: ≥ 8 RBC units / 16 weeks
  • Pre-treatment Hgb levels <10 g/dL
  • At least 2 transfusion events and 1 in each of the 2 consecutive 8 weeks
    blocks over 16 weeks
• Subjects must be refractory (≥4 weeks of treatment), intolerant (any duration of
  treatment), or unlikely to respond to ESA treatment (EPO > 200 U/L)
• Subjects must have less than 5% blasts in an evaluable bone marrow aspirate
  collected at screening
• Subjects with del(5q) MDS, therapy-related (secondary) MDS, or any known
  history of AML are excluded
• Subjects with anemia due to any other known cause are excluded