Catabasis expects Investigational New Drug application in 1H 2022

“With our acquisition of Quellis and concurrent financing, we believe Catabasis is well positioned to advance the development of our lead program, QLS-215, as a differentiated and potential best-in-class new therapy for the chronic treatment of patients affected by HAE to prevent attacks,” says Jill C. Milne, Ph.D., CEO of Catabasis Pharmaceuticals, Inc., at the presentation of a corporate update.“QLS-215 is a monoclonal antibody inhibitor of plasma kallikrein in preclinical development, which we believe has the potential to demonstrate clinical proof of concept of its differentiated profile in Phase 1. Our mission has always been to bring hope with life-changing therapies to patients and their families affected by rare disease.”

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 inhibitory blood levels. QLS-215 is a humanized monoclonal antibody targeting plasma kallikrein that has demonstrated potent inhibition of plasma kallikrein as well as an 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 1a 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.
(Source: Catabasis)

2021-03-12T15:04:35+02:00March 12, 2021|HAEi News|