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    Martz L. Kidney is the new liver: why kidney indications are coming into sharp focus. Biocentury Innovations. Oct. 3, 2019.

Clinical Trials Planned for FSGS, Diabetic Nephropathy Agents

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Two companies recently announced clinical trials for promising drug candidates for kidney diseases.

Goldfinch Bio (Cambridge, MA) is entering into an agreement with Osaka, Japan–based Takeda to develop a drug to treat rare and metabolic kidney diseases. The agreement will grant Takeda worldwide rights to the cannabinoid receptor 1 (CB1) monoclonal antibody, which inhibits CB1. Goldfinch says terms are not being disclosed.

The company will assume development and commercialization responsibilities for the drug. Takeda reserves the right, however, to request that Goldfinch Bio negotiate with Takeda for sub-licensing of Japanese rights to the pharmaceutical.

A therapeutic agent will be developed from the preclinical CB1 monoclonal antibody, which has been renamed GFB-024. Goldfinch plans to file a new drug application and begin a phase 1 study in the second half of 2020.

Preclinical data support the inhibition of CB1 signaling as a novel treatment of two kidney-related conditions tracking with the obesity epidemic, diabetic nephropathy and obesity-related glomerulopathies (ORG). The compound potentially will provide metabolic benefits, help prevent fibrosis, and preserve kidney function, the company says.

Diabetic nephropathy develops in 30% to 40% of patients who have diabetes and is a leading cause of morbidity, mortality, and kidney failure in the United States and worldwide. ORG is a rare kidney disorder characterized by significant proteinuria and progressive renal dysfunction.

The Phase 2a clinical trial of ZyVersa Therapeutic’s drug candidate VAR200 should begin by year’s end. ZyVersa, based in Weston, FL, targets podocyte cholesterol accumulation that results from impaired efflux of cholesterol from the cells, causing structural damage that affects kidney filtration. The treatment would benefit patients with focal segmental glomerulosclerosis.

The article “Kidney is the New Liver” states: “Within the past 5 years, renal drug development has been de-risked due to FDA’s acceptance of short-term surrogate endpoints, such as proteinuria, and the ability to segment patients into homogeneous groups through AI and machine learning from large patient data bases, such as Neptune. This has resulted in a surge of interest and investment in this area, as was seen in the past with liver disease” (1).



Martz L. Kidney is the new liver: why kidney indications are coming into sharp focus. Biocentury Innovations. Oct. 3, 2019.