07 March 2019 | News
The trial is being conducted in Australia and will enroll up to 72 healthy female subjects.
Kezar Life Sciences, a South San Francisco-based clinical-stage biotechnology company discovering and developing novel small molecule therapeutics to treat unmet needs in autoimmunity and cancer has announced the initiation of a Phase 1, randomized, double-blind, placebo controlled, single and multiple ascending dose trial to assess the safety, tolerability, pharmacokinetics and target inhibition of a simplified lyophilized formulation of KZR-616. The trial is being conducted in Australia and will enroll up to 72 healthy female subjects. A simplified lyophilized formulation of KZR-616 has the potential to improve the ease of drug administration, transportation and storage, which we believe may result in increased patient adoption in a commercial setting. Additionally, data from this trial may be used to support development and potential regulatory approval.
“The initiation of this trial propels us towards creating a novel, patient-friendly treatment,” said Niti Goel, MD, Chief Medical Officer. “We remain motivated by the potential of KZR-616, our first-in-class immunoproteasome inhibitor, to provide a meaningful clinical benefit to patients where limited treatments options exist. We look forward to reporting top-line results from the first two cohorts of our ongoing Phase 1b/2 trial during the second quarter of this year.”
Kezar Life Sciences is a clinical-stage biotechnology company committed to revolutionizing treatments for patients with autoimmune diseases and cancer. Kezar is translating its innovative research on the immunoproteasome and protein secretion pathways to advance novel therapeutic approaches. KZR-616, a first-in-class immunoproteasome inhibitor, is currently in a Phase 1b trial, with a Phase 2 trial in lupus nephritis patients expected to initiate during the first half of 2019. Kezar is also poised to expand its development programs throughout 2019 with plans to initiate Phase 2 trials of KZR-616, in up to four additional autoimmune indications, and to nominate an initial clinical candidate for the treatment of cancer from its protein secretion program.