Yesterday afternoon, clinical-stage biotechnology company Kezar Life Sciences Inc. (KZR:NASDAQ), which is focused on the discovery and development of treatments for immune-mediated and oncologic disorders, announced "interim results from the Phase 2 portion of its MISSION clinical trial evaluating KZR-616, a first-in-class selective immunoproteasome inhibitor, in patients with active, proliferative lupus nephritis (LN)."
Kezar Life Sciences' Chief Medical Officer Noreen R. Henig, M.D. commented, "The MISSION Phase 2 interim results present a strong signal that KZR-616 is active and could be a meaningful therapy for patients with lupus nephritis, a long term and difficult to treat disease…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. KZR-616 continues to appear to be immunomodulatory rather than immunosuppressive, which we believe could offer advantages over current treatments available. Based on these interim findings, we look forward to reporting top-line data in the second quarter of 2022."
MISSION study investigator Samir V. Parikh, M.D., Associate Professor of Medicine, Division of Nephrology, The Ohio State University Wexner Medical Center, added, "these interim results are important for patients living with lupus nephritis. One of the devastating consequences of the disease is kidney failure, so new immunomodulatory treatments that have the potential to protect kidney function would fulfill a substantial unmet need and could lead to better long-term outcomes."
The company explained that the Phase 2 MISSION study is designed to evaluate the responder rate of KZR-616 in lupus nephritis patients. Kezar advised that the pre-established primary endpoint in the study is "the proportion of patients achieving a renal response measured by a 50% or greater reduction in urine protein to creatinine ratio (UPCR) at end of treatment." An additional secondary efficacy endpoint was identified to measure the number of patients who demonstrated either a complete renal response (CRR) or partial renal response (PRR).
Participants in the trial are subcutaneously administered one 30 mg dose of KZR-616 followed by 24 weekly 60 mg doses and are assessed at week 25. The firm noted that patients in the study are not given standard induction therapy, which is a combination of cyclophosphamide and corticosteroids, pointing out that this represents a significant difference in approaches of other recently conducted lupus nephritis trials.
The company indicated that the interim analysis provided was from 5 patients in the study who had completed the treatment period and 10 others who reached the halfway point of 13 weeks of treatment.
The firm outlined some of the key findings from the interim trial data and claimed that patients treated with KZR-616 demonstrated clinically meaningful renal response at the end of treatment. The results indicated that 3 of 5 patients successfully achieved the primary efficacy endpoint goal in the study of a 50% or greater reduction in UPCR at week 25 and added that 4 of the 5 individuals who completed the full scheduled treatment demonstrated a clinically meaningful reduction in proteinuria to less than 0.8 UPCR.
The firm advised further that significant reductions in UPCR were also observed in 5 of 10 patients given KZR-616 up to the studies midpoint and those included participants also showed improvements in several key disease biomarkers. The company stated that KZR-616 was well tolerated during the six-month treatment period throughout the Phase 3 MISSION trial and that no new safety signals were observed. Kezar advised that top-line data from MISSION study is expected to be available in Q2/22.
The firm explained that "lupus nephritis (LN) is one of the most serious complications of systemic lupus erythematosus (SLE) and added that the disease comprising a spectrum of vascular, glomerular and tubulointerstitial lesions and develops in approximately 50% of SLE patients within 10 years of their initial diagnosis." LN often leads to high mortality rates. The disease frequently progresses to end-stage renal disease requiring dialysis or transplants with increased risk of death.
Kezar Life Sciences is a clinical-stage biopharmaceutical company based in South San Francisco, Calif. that concentrates its efforts on the development of novel treatments for immune-mediated and oncologic disorders. The firm is creating and investigating small-molecule therapies that harness what it calls "master regulators" of cellular function, protein degradation and protein secretion, in order to inhibit multiple drivers of disease via single, powerful targets. The firm's lead drug in its development pipeline is a selective immunoproteasome inhibitor, KZR-616, which at present is being tested in Phase 2 clinical trials in lupus nephritis, dermatomyositis and polymyositis. Additionally, the company's first anti-cancer clinical candidate, KZR-261, is now being evaluated in a Phase 1 solid tumor study.
Kezar Life Sciences started the day with a market cap of around $413.3 million with approximately 49.15 million shares outstanding and a short interest of about 4.8%. KZR shares opened more than 40% higher today at $11.98 (+$3.57, +42.45%) over yesterday's $8.41 closing price and reached a new 52-week high price this morning of $12.46. The stock has traded today between $10.5701 and $12.46 per share and is currently trading at $11.16 (+$2.75, +32.70%).
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