Goldfinch Bio, Takeda sign deal for CB1 monoclonal antibody to treat rare and metabolic kidney diseases

Goldfinch Bio will assume all development and commercialization responsibilities for the treatment of rare and metabolic kidney diseases worldwide. However, the agreement grants Takeda 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 Bio plans to file an investigational new drug (IND) application for this CB1 inhibitor, re-named GFB-024, in the second half of 2020.

“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, M.D., President and Chief Executive Officer of Goldfinch Bio.

“Goldfinch Bio will deploy its biology platform and Kidney Genome Atlas^TM to develop this therapeutic agent in subsets of patients with kidney diseases most likely to preferentially respond to CB1 inhibition. With GFB-887, our TRPC5 inhibitor for FSGS, in Phase 1 clinical development, this peripheral CB1 inhibitor will be the second clinic-ready program in Goldfinch Bio’s pipeline. We look forward to collaborating with Takeda on this program.”

“Goldfinch Bio is ideally suited to advance development of this program,” said Dan Curran, M.D., SVP and Head, Rare Diseases Therapeutic Area Unit, Takeda. “The application of its precision medicine approach, from candidate target validation through to identification of potential treatment-relevant subgroups, is unique in the development of chronic metabolic kidney disease treatments.”

Preclinical data support the inhibition of CB1 signaling as a novel treatment of Diabetic Nephropathy (DN) and obesity-related glomerulopathies (ORG), given the potential metabolic benefits and direct effects on the kidney to prevent fibrosis and preserve kidney function.

DN 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. ORG is a rare kidney disorder characterized by significant proteinuria and progressive renal dysfunction. Although both DN and ORG are increasing in prevalence in parallel with the obesity epidemic, well-established disease modifying therapies are lacking. Goldfinch Bio plans to initiate a phase 1 study for GFB-024 in 2H 2020.

Source: Company Press Release