Health and Healthcare
Is This Kezar Life Sciences Lupus Study in Trouble?
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Kezar Life Sciences Inc. (NASDAQ: KZR) shares were absolutely crushed on Tuesday after the firm revealed data from its midstage trial in patients with systemic lupus erythematosus (SLE).
The data will be presented at the European League Against Rheumatism (EULAR) 2019 annual meeting taking place in Spain June 12 to 15.
The preliminary results came out when the firm announced that data from the first two cohorts of an open-label dose escalation trial of KZR-616 in SLE. The efficacy data seemed less than impressive, and two healthy volunteers required hospitalization.
The Phase 1a clinical trial results in healthy volunteers provided evidence that KZR-616 potentially avoids adverse effects caused by currently marketed non-selective proteasome inhibitors, which the firm believes prevent them from being utilized as a chronic treatment in autoimmune disorders.
A Phase 1b/2 trial (MISSION study) of KZR-616 in SLE patients and lupus nephritis patients is currently underway. Phase 2 trials in dermatomyositis, polymyositis, autoimmune hemolytic anemia and immune thrombocytopenia are expected to commence in the second half of 2019.
Niti Goel, M.D., FACR, Kezar’s chief medical officer, commented:
Presenting our first in patient data with KZR-616, our novel selective immunoproteasome inhibitor, is an important milestone for Kezar and represents the culmination of several years of our team’s research and development efforts. We are encouraged by the safety, tolerability, and potential efficacy seen thus far in the MISSION trial and look forward to sharing the detailed results with the clinical and scientific community next month. The Phase 2 portion in lupus nephritis patients has commenced enrollment, and we have identified 30 and 45mg as the appropriate doses to advance in each of our Phase 2 autoimmune clinical trials. We expect to initiate trials with KZR-616 in dermatomyositis, polymyositis, autoimmune hemolytic anemia, and immune thrombocytopenia later this year.
Shares of Kezar were last seen down about 42% at $9.70, in a 52-week range of $9.64 to $36.33. The consensus price target is $29.50.
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