Chinook Therapeutics To Present Updated Data From Zigakibart Phase 1/2 Trial In Patients With IgA Nephropathy At The 60th European Renal Association Congress

Author: Benzinga Newsdesk | June 12, 2023 04:07pm

• Zigakibart treatment continues to demonstrate rapid and sustained reductions in mechanistic biomarkers, including IgA and Gd-IgA1 levels, which correspond to clinically meaningful proteinuria reductions in patients with IgAN across Cohorts 1 and 2
  
  
  
   
• Zigakibart is well-tolerated, with no ADAs observed or treatment discontinuations due to adverse events (AEs) in patients with IgAN across Cohorts 1 and 2
  
  
  
   
• In all patients combined from both Cohorts 1 and 2, zigakibart demonstrated mean proteinuria reductions of 20% at 12 weeks of treatment, 39% at 24 weeks of treatment and 67% at 52 weeks of treatment
  
  
  
   
• Extended treatment with zigakibart resulted in sustained clinical benefit, with 67% mean proteinuria reduction in seven patients at 76 weeks of treatment and 72% in five patients at 100 weeks of treatment
  
  
  
   
• Additional presentations on the phase 2 ASSIST and phase 3 BEYOND study designs, initial data from the phase 1 study of CHK-336 in healthy volunteers, as well as research on the impact of maladaptive tubular epithelial cells on disease progression in chronic kidney diseases will also be presented at the 60th ERA Congress
  
  
  
   
• Due to the pending acquisition of Chinook by Novartis AG, the investor conference call and webcast previously scheduled for Friday, June 16, 2023 at 8:15 am EDT (2:15 pm CEST) has been cancelled
  
   

SEATTLE, June 12, 2023 (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 a focused oral presentation on zigakibart (BION-1301) will be presented on Friday, June 16, 2023 at the 60th ERA Congress being held virtually and live in Milan, Italy.

"The strong data we will be presenting at the ERA Congress from the ongoing phase 1/2 study of zigakibart continue to demonstrate its disease-modifying potential in patients with IgAN," said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. "In addition to sustained reductions in mechanistic biomarkers and correlating clinically meaningful proteinuria reductions observed in patients with IgAN with a wide range of baseline proteinuria levels, the phase 1/2 study has provided us additional key learnings that we look forward to implementing in the phase 3 BEYOND trial, including dose, schedule and route of administration and patient selection."

Updated Interim Results of a Phase 1/2 Study of Zigakibart (BION-1301) in Patients with IgA Nephropathy

Zigakibart is a novel anti-APRIL monoclonal antibody currently in phase 2 clinical development for patients with IgAN. Blocking APRIL is a potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1).

Updated data from both Cohorts 1 and Cohort 2 will be presented from Part 3 of the ongoing phase 1/2 multi-center trial (see www.clinicaltrials.gov, identifier NCT03945318) evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical responses of open-label zigakibart treatment in patients with IgAN.

Key highlights from the presentation include the following:

Patients in Cohort 1 initially received a 450mg intravenous (IV) dose of zigakibart every two weeks. After at least 24 weeks of IV dosing, patients in Cohort 1 transitioned to a 600 mg subcutaneous (SC) dose every two weeks for a total treatment duration of up to two years. Cohort 1 enrolled 10 patients, of which two patients withdrew from the study for reasons unrelated to study drug, and eight patients continued receiving treatment.

Patients in Cohort 2 are receiving a SC dose of 600 mg of zigakibart every two weeks for a total treatment duration of up to two years. Cohort 2 enrolled 30 patients, of which three patients were discontinued for not meeting the eligibility criterion of having biopsy-confirmed IgAN, and 27 patients continued receiving treatment.

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