Chinook Therapeutics Presents Data Across Kidney Disease Pipeline During the American Society of Nephrology (ASN) Kidney Week 2020 Reimagined - Seite 2

Chinook’s Phase 3 ALIGN trial (see www.clinicaltrials.gov, identifier NCT04573478), which is planned to begin enrollment in early 2021, will assess the efficacy, safety and tolerability of atrasentan in IgA nephropathy patients at risk of progressive kidney function loss. Approximately 320 patients across North America, South America, Europe and Asia-Pacific with biopsy-proven IgA nephropathy who are already on a maximally tolerated and stable dose of RASi will be randomized to receive 0.75 mg atrasentan or placebo daily for 132 weeks. The study will also include a cohort of patients who are unable to tolerate RASi. Patients will have assessments of safety and efficacy over 2.5 years. An open-label extension will allow participants who complete the study to receive active atrasentan.

• The primary endpoint for the ALIGN study is change in proteinuria, based on paired 24-hour urine collections from baseline to week 24.
  
  
• The key secondary endpoint for the study is change in estimated glomerular filtration rate (eGFR) from baseline to week 136, which is four weeks after discontinuation of treatment.
  
  
• Key patient enrollment criteria for the ALIGN study include ≥18 years of age, a history of biopsy-proven IgA nephropathy, a urinary protein to creatinine ratio (UPCR) of at least 1g/g based on a first morning void sample, eGFR of at least 30ml/min, no recent use of systemic immunosuppressants and no other cause of other chronic kidney disease.
  

PO1843: Results of a Phase 1 Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers

BION-1301 is a novel anti-APRIL monoclonal antibody currently in phase 1 clinical development for IgA nephropathy. Blocking APRIL is a potential disease-modifying approach to treating IgA nephropathy by reducing circulating levels of galactose-deficient IgA to prevent the formation of immune complexes that deposit in the glomeruli of the kidney, causing damage.

The ongoing phase 1 multi-center trial (see www.clinicaltrials.gov, identifier NCT03945318) evaluated the safety and tolerability of BION-1301 in 63 healthy volunteers in double-blinded, placebo-controlled single-ascending dose (SAD) and multiple-ascending dose (MAD) settings. Healthy volunteers in the SAD portion of the study received placebo or a single intravenous (IV) dose of BION-1301 ranging from 10 mg to 1350 mg on day 1. Healthy volunteers in the MAD portion of the study received placebo or IV doses of BION-1301 ranging from 50 mg to 450 mg on days 1, 15 and 29 (three doses total).