CHK-336

Phalguni Deswal @Phalguni_GD The shareholders would also be eligible to receive an additional $4 per share contingent (totalling $300m) on regulatory milestones. Image Credit: JHVEPhoto / Shutterstock. Novartis has acquired Chinook Therapeutics for more than $3.2bn in a move to bolster its portfolio of drugs targeting kidney disease. With reported sales of $13.62bn in Q2 2023 , Novartis is looking to expand its drug portfolio. Just last month, the company acquired DTx Pharma for $1bn for its small interfering RNA (siRNA) treatment portfolio for rare diseases. Recommended Reports Reports Chronic Myeloid Leukemia (CML): Global Drug Forecast and Market Analysis to 2030 GlobalData Reports HER2+ Breast Cancer - Global Drug Forecast and Market Analysis to 2030 GlobalData View all Companies Intelligence Novartis AG Chinook Therapeutics Inc Era Spa DTx Pharma Inc Kidney Research UK View all As part of Chinook’s acquisition, its shareholders would receive $40 per share, totalling $3.2bn. The shareholders would also be eligible to receive an additional $4 per share contingent (totalling $300m) on regulatory milestones. The acquisition comes at a significant inflection point with two high-profile drugs, atrasentan and zigakibart, in Phase III development for the treatment of IgA nephropathy (IgAN). A pivotal data readout for the Phase III atrasentan trial is planned for Q4 2023. IgAN is a chronic kidney disease, in which immunoglobulin A (IgA) is trapped in the glomeruli of the kidney, thereby causing kidney scarring and damage. As per the charity Kidney Research UK, the current treatment for the disease includes symptomatic control, blood pressure medications that can also reduce proteinuria (a common symptom of IgAN), and immunosuppressants. Zigakibart is a subcutaneous monoclonal antibody that targets a proliferation-inducing ligand (APRIL). The Phase III trial began in July 2023, with the goal of enrolling 272 participants. The primary endpoint for the study is the change in proteinuria from baseline in the treatment group, compared to a placebo. Atrasentan is an oral endothelin A receptor antagonist (ERA), which is currently in a placebo-controlled Phase III trial (NCT04573478) for IgAN. Based on available data, Chinook says atrasentan causes a significant reduction in proteinuria compared to placebo. Chinook’s portfolio also consists of drugs in early phases of development including CHK-336, for treating primary hyperoxaluria (PH) and other kidney stone disorders , its development is on pause due to a serious adverse event observed in its Phase I study.

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 BEYOND study, a pivotal phase 3 clinical trial evaluating the safety and efficacy of zigakibart (BION-1301), a potentially disease-modifying anti-APRIL monoclonal antibody. “Initiation of the phase 3 BEYOND study is an important step towards our goal of providing an innovative treatment option for patients with IgAN, a disease with high unmet need and limited treatment options,” said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. “The data from our ongoing phase 1/2 trial of zigakibart supports our belief that binding and neutralizing APRIL in patients with IgAN plays a key role in depleting pathogenic galactose deficient-IgA1, reducing proteinuria and preserving kidney function for IgAN patients.” “I am pleased to see Chinook enroll the first patient in the phase 3 BEYOND study of zigakibart in IgAN and look forward to the study’s continued enrollment,” said Vlado Perkovic, MBBS, PhD, FASN, FRACP, dean of medicine and health and Scientia professor at University of New South Wales and co-chair of the BEYOND study steering committee. “IgAN is the most common primary glomerular disease worldwide with limited treatment options currently available, causing many patients to progress to end-stage kidney disease, requiring dialysis or kidney transplant. With the potential to be disease-modifying based on the encouraging results observed in the phase 1/2 study, I believe zigakibart could be an important new therapeutic treatment option for patients with IgAN.” About the BEYOND Study The BEYOND study (see www.clinicaltrials.gov, identifier NCT05852938) is a global, randomized, multicenter, double-blind, placebo-controlled phase 3 clinical trial comparing the safety and efficacy of zigakibart versus placebo in patients with IgAN at risk of progressive loss of kidney function. Approximately 272 patients with biopsy-proven IgAN and eGFR ≥ 30 mL/min/1.73m2 will be randomized to receive 600 mg of zigakibart or a matched placebo subcutaneously every two weeks for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 subjects (10 subjects per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to 2. The primary efficacy endpoint of the BEYOND study is to evaluate the effect of zigakibart versus placebo on proteinuria as measured by change in urine protein to creatinine ratio (UPCR) from baseline to 40 weeks. Secondary and exploratory objectives include evaluating change in eGFR from baseline to week 104; composite clinical outcome of 30% or 40% reduction in eGFR, eGFR 2 or dialysis, kidney transplantation or all-cause mortality; safety and tolerability; impact of zigakibart on disease biomarkers and health-related quality of life, as well as analysis of zigakibart pharmacokinetics and immunogenicity. About Chinook Therapeutics, Inc. Chinook Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and proteinuric glomerular diseases. Zigakibart (BION-1301), an anti-APRIL monoclonal antibody, is being evaluated in a phase 3 trial for IgA nephropathy. CHK-336, an oral small molecule LDHA inhibitor for the treatment of hyperoxalurias, is in phase 1 development. In addition, Chinook’s research and discovery efforts are focused on building a pipeline of precision medicines for rare, severe chronic kidney diseases with defined genetic and molecular drivers. Chinook is leveraging insights from kidney single cell RNA sequencing and large CKD patient cohorts that have been comprehensively panomically phenotyped, with retained biosamples and prospective clinical follow-up, to discover and develop therapeutic candidates with mechanisms of action targeted against key kidney disease pathways. To learn more, visit www.chinooktx.com. The content above comes from the network. if any infringement, please contact us to modify.