Catabasis Using $110M Investment to Advance QLS-215 Therapy
Catabasis Pharmaceuticals will use a $110 million private investment to complete preclinical and early clinical studies evaluating QLS-215, its investigational kallikrein-inhibitor therapy for hereditary angioedema (HAE).
QLS-215 became Catabasis’ lead product after it acquired the original developer, Quellis Biosciences, in January 2021. Now, the company plans to file an application requesting that QLS-215 enter clinical testing in the first half of 2022.
“Our mission has always been to bring life-changing therapies to patients and families affected by rare diseases,” Kenneth Bate, chair of Catabasis’ board of directors, said in a press release.
“We look forward to progressing QLS-215, a differentiated and potential best-in-class new therapy for patients affected by HAE,” Bate said.
In HAE, a deficiency in the functional C1-inhibitor protein results in the increased activity of an enzyme called kallikrein. That excess activity in turn increases the levels of the inflammatory mediator bradykinin, causing blood vessels to dilate and tissue to swell.
QLS-215 is a humanized monoclonal antibody designed for the routine prevention of HAE attacks by targeting kallikrein. While it works similarly to Takhzyro (lanadelumab) — an approved therapy for HAE — previous studies in the laboratory and in non-human primates showed that QLS-215 is more potent in inhibiting the bradykinin production. The new therapy also has greater stability in the blood.
According to the company, the potential benefits of QLS-215 include small injection volume, less frequent dosing, sustained blood levels, and a long duration without breakthrough attacks.
After completing preclinical studies that support the initiation of clinical trials, the company plans to launch a Phase 1a study. Catabasis said that trial will test single ascending doses of QLS-215 in a group of healthy volunteers. The goal is to demonstrate that the treatment is safe and to confirm its longer durability. Results are expected by the end of 2022.
Subsequently, a Phase 1b/2 clinical trial will evaluate the safety and effectiveness of multiple ascending doses of QLS-215 in patients whose HAE is caused by a deficiency in the C1-inhibitor protein. That trial is expected to start in 2023, with preliminary results anticipated by the end of that year.
“We are thrilled that the Catabasis Board and management team selected Quellis as the best acquisition opportunity based on our lead asset, QLS-215, and the vision to produce a leading HAE and rare disease company,” said Chris Garabedian, chair of Quellis’ board of directors.
After completion of the acquisition and private placement financing, Catabasis expects to have total funding of approximately $150 million, according to the release.