After the acquisition of Quellis Biosciences Inc., Catabasis Pharmaceuticals, Inc. expects to enable the completion of IND-enabling studies, Phase 1a, and Phase 1b/2 clinical trials for the lead program QLS-215 in HAE.
“Our mission has always been to bring life-changing therapies to patients and families affected by rare diseases. We look forward to progressing QLS-215, a differentiated and potential best-in-class new therapy for patients affected by HAE”, says Kenneth Bate, Chair of the Catabasis Board of Directors.
The vision for QLS-215 is to develop the best-in-class monoclonal antibody inhibitor of plasma kallikrein for HAE with infrequent dosing and sustained blood levels. QLS-215 is a humanized monoclonal antibody targeting plasma kallikrein that has demonstrated potent inhibition of plasma kallikrein as well as extended plasma half-life in non-human primates. Catabasis expects to file an Investigational New Drug application for QLS-215 in the first half of 2022 and plans to initiate a Phase 1 clinical trial with initial results anticipated by the end of 2022. Subsequently, Catabasis expects to initiate a Phase 1b/2 trial in patients affected by HAE in 2023 with initial results anticipated by the end of 2023.