Kezar Life Sciences Touts Positive Data From Mid-Stage Study For Chronic Liver Disease Drug Candidate

On Tuesday, Kezar Life Sciences, Inc. KZR revealed topline results from the PORTOLA Phase 2a trial evaluating zetomipzomib for autoimmune hepatitis (AIH), a chronic liver disease where the body’s immune system attacks healthy liver cells, causing inflammation and potential damage.

Top-line data shows that zetomipzomib treatment resulted in higher rates of complete biochemical responses (CR) combined with the reduction of steroid dosage to 5 mg/day or less compared to placebo.

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In the ITT population:

• Without regard to steroid taper (decrease slowly), 50.0% (8 of 16) of zetomipzomib patients achieved a CR, compared to 37.5% (3 of 8) of placebo patients.
• 31.3% (5 of 16) of zetomipzomib patients achieved a CR and steroid taper to 5 mg/day or less, compared to 12.5% on placebo.
• 18.8% (3 of 16) of zetomipzomib patients achieved both a CR and complete steroid withdrawal to zero mg/day, compared to 0% on placebo patients.
• The median duration of response in zetomipzomib patients achieving a CR was 27.6 weeks and no disease flares were reported in any zetomipzomib-treated patient achieving CR.

In the pre-specified subgroup analysis, 21 of the 24 patients entered the study on a steroid-based therapy at the time of screening:

• Without regard to steroid taper, 57.1% (8 of 14) of zetomipzomib patients achieved a CR compared to 28.6% (2 of 7) of placebo patients.
• 35.7% (5 of 14) of patients on the zetomipzomib arm achieved a CR and steroid taper to 5 mg/day or less, compared to 0% (0 of 7) of placebo patients.
• 21.4% (3 of 14) of patients on the zetomipzomib arm achieved a CR and complete steroid withdrawal to zero mg/day, compared to 0% (0 of 7) of placebo patients.

Treatment-emergent adverse events were seen in all patients, with injection site reactions being the most commonly reported TEAE in both arms.

Price Action: KZR stock was down 9.09% at $5.60 during the premarket session at the last check Tuesday.

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