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 application for this 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.
DN develops in 30 to 40% 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.
Goldfinch Bio, Inc. is a clinical stage biotechnology company that leverages a genomics-based, precision medicine approach to discovering and developing kidney disease treatments.
Its Kidney Genome Atlas is a proprietary biology platform that drives candidate discovery, patient selection and biomarker development.
The company's lead candidate, GFB-887, is a subtype-selective, small molecule TRPC5 being evaluated in a Phase 1 clinical trial for the treatment of kidney diseases. Goldfinch Bio, headquartered in Cambridge, Massachusetts, was launched in 2016 by Third Rock Ventures and has an established strategic collaboration with Gilead Sciences, Inc.
Nuevocor names new chief medical officer
ELIAS Animal Health names new chief revenue officer
enGene Holdings names new senior vice president, Urologic Oncology and Clinical Development
HealthTrackRx names new chief medical officer
PureTech announces launch of Seaport Therapeutics with USD100m Series A financing
REVIAN names new vice president of Healthcare Sales
Orsini Specialty Pharmacy names new CFO and EVP of Trade Relations and Account Management
Ligand Pharmaceuticals launches Pelthos Therapeutics to drive ZELSUVMI commercialisation
Soligenix announces agreement on design for second Phase 3 trial for HyBryte with EMA
Ratio Therapeutics names new chief business officer and director
Trevi Therapeutics names new vice president of Clinical Development
NeoImmuneTech names new president and chief executive officer