Kezar Life Sciences, Inc. KZR shares are soaring Tuesday following a positive clinical readout.
What Happened: California-based Kezar announced positive interim results from the Phase 2 portion of the MISSION clinical study evaluating KZR-616 in patients with lupus nephritis.
For the interim analysis, five patients had reached the end of treatment, and ten patients had reached week 13.
At the end of the treatment period, three of the five patients achieved a 50% or greater reduction in urine protein to creatinine ratio, or UPCR, compared to baseline, thus meeting the study's primary efficacy endpoint.
The company noted that four of the five patients who completed treatment at Week 25 showed a clinically meaningful reduction in proteinuria to less than 0.8 UPCR. Of these, two patients showed a complete response rate, and two showed a partial response rate.
At Week 13, KZR-616 induced clinically meaningful reductions in UPCR in five of the 10 patients and improvements in key disease biomarkers. On the safety front, the investigational asset was well tolerated over the six-month treatment period.
Why It's Important: Kezar's pipeline consists of three investigational compounds, including KZR-616. KZR-616 is being evaluated in two Phase 2 studies – in Lupus nephritis and dermatomyositis polymyositis.
Lupus nephritis is one of the most serious complications of systemic lupus erythematosus. It increases the risk of end-stage renal disease requiring dialysis or renal transplantation and death.
There are limited approved therapies for treating lupus nephritis, and its management typically consists of induction therapy to achieve remission and long-term maintenance therapy to prevent relapse.
"Reduction in proteinuria, as quickly as possible, is an important therapeutic goal for patients with lupus nephritis, and we observed meaningful reductions at 6 months as well as encouraging data at 3 months," said Noreen Henig, Kezar's chief medical officer
"KZR-616 continues to appear to be immunomodulatory rather than immunosuppressive, which we believe could offer advantages over current treatments available." The company expects to report top-line data from the study in the second quarter of 2022.
Price Action: In premarket trading Tuesday, Kezar shares were jumping 53% at $12.87.
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