RARE Daily

Goldfinch Enters Licensing Agreement with Takeda for Rare And Metabolic Kidney Diseases

October 4, 2019

Goldfinch Bio Announces Licensing Agreement with Takeda for Rare And Metabolic Kidney Diseases Therapy

Rare Daily Staff

Goldfinch Bio has entered into a license agreement with Takeda Pharmaceutical for worldwide rights to a preclinical, peripherally-restricted cannabinoid receptor 1 (CB1) monoclonal antibody it will develop for rare and metabolic kidney diseases worldwide.

Under terms of the agreement, Goldfinch Bio will assume all development and commercialization responsibilities. Takeda, though, has the option, prior to the initiation of pivotal studies, to request Goldfinch Bio negotiate with Takeda for sub-licensing of Japanese rights to Takeda. Financial terms of the agreement were not disclosed.

Goldfinch said it plans to file an investigational new drug application for the CB1 inhibitor, re-named GFB-024, in the second half of 2020.

Preclinical data support the inhibition of CB1 signaling as a novel treatment of diabetic nephropathy and obesity-related glomerulopathies, given the potential metabolic benefits and direct effects on the kidney to prevent fibrosis and preserve kidney function. Diabetic neuropathy develops in 30 to 40 percent of patients who have diabetes and is a leading cause of morbidity, mortality and end-stage kidney disease in the United States and worldwide. Obesity-related glomerulopathies is a rare kidney disorder characterized by significant proteinuria and progressive renal dysfunction. Although both are increasing in prevalence in parallel with the obesity epidemic, well-established disease modifying therapies are lacking.

“In recent years, our understanding of the role of CB1 signaling in exacerbating progressive kidney diseases has grown substantially. In this context, a monoclonal antibody directed toward the CB1 receptor is potentially well-suited to elicit the beneficial pharmacology associated with the peripheral inhibition of the CB1 receptor,” said Anthony Johnson, president and CEO of Goldfinch Bio. “Goldfinch Bio will deploy its biology platform and Kidney Genome Atlas to develop this therapeutic agent in subsets of patients with kidney diseases most likely to preferentially respond to CB1 inhibition.”

Photo: Anthony Johnson, president and CEO of Goldfinch Bio.

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