Chinook Therapeutics Announces First Patient Enrolled in Pivotal Phase 3 ALIGN Study of Atrasentan for Patients with IgA Nephropathy

Phase 2 AFFINITY Trial of Atrasentan for Patients with Glomerular Diseases Also on Track to Begin Enrollment in the First Half of 2021

VANCOUVER, British Columbia and SEATTLE, March 16, 2021 (GLOBE NEWSWIRE) -- Chinook Therapeutics, Inc. (NASDAQ: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today announced that the first patient with IgA nephropathy (IgAN) has been enrolled in the ALIGN Study, a pivotal phase 3 clinical trial evaluating the efficacy and safety of atrasentan, a potent and selective inhibitor of the endothelin A receptor.

“The initiation of the phase 3 ALIGN Study is an important milestone for Chinook as we advance our pipeline of programs for rare, severe chronic kidney diseases,” said Alan Glicklich, M.D., chief medical officer of Chinook. “Atrasentan has been studied in over 5,300 diabetic kidney disease patients in the phase 2 RADAR and phase 3 SONAR studies, demonstrating rapid, sustained proteinuria reductions of approximately 30 to 35 percent as well as improved eGFR. Importantly, treatment with atrasentan also resulted in a reduction in clinical outcomes of development of end-stage kidney disease and doubling of serum creatinine. We look forward to exploring the proteinuria-lowering, anti-inflammatory and anti-fibrotic effects of atrasentan in patients with IgA nephropathy, a serious progressive disease for which there are no approved therapies.”

“I am pleased to see Chinook kick off the well-designed phase 3 ALIGN Study of atrasentan in IgA nephropathy. Given the strong correlation between endothelin system activation and disease progression, and the drug’s demonstrated impact on proteinuria in patients with diabetic nephropathy, I believe atrasentan will be a beneficial therapeutic treatment option for patients with IgA nephropathy,” said Jonathan Barratt, Ph.D., F.R.C.P, the Mayer professor of renal medicine at University of Leicester, honorary consultant nephrologist at Leicester General Hospital and co-chair of the ALIGN Study steering committee.

About the ALIGN Study
The ALIGN Study (see www.clinicaltrials.gov, identifier NCT04573478) is a global, randomized, multicenter, double-blind, placebo-controlled phase 3 clinical trial comparing the efficacy and safety of atrasentan versus placebo in patients with IgAN at risk of progressive loss of kidney function. Approximately 320 patients with biopsy-proven IgAN will be randomized to receive 0.75 mg atrasentan or placebo as a once-daily oral pill for approximately 2.5 years. Patients will continue receiving a maximally tolerated and stable dose of a RAS inhibitor as standard of care. The study will also include a cohort of patients that are unable to tolerate RAS inhibitor therapy.