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Goldfinch Bio Announces Open Label Extension Study for Focal Segmental Glomerular Sclerosis (FSGS) Patients Enrolled in Phase 2 Clinical Trial of GFB-887

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– GFB-887, the company’s flagship product candidate for precision kidney medicine, is a very potent and selective inhibitor of the TRPC5-Rac1 pathway –

– Over-activation of the TRPC5-Rac1 pathway is the leading cause of disease in a substantial portion of patients with FSGS and other kidney diseases –

CAMBRIDGE, Massachusetts, August 10, 2021– (BUSINESS WIRE) – Goldfinch Bio, a clinical-stage biotechnology company focused on the discovery and development of precision drugs for the treatment of kidney disease, today announced that it has administered the first patient in a study of open-label extension for segmental glomerular sclerosis (FSGS) patients enrolled in its TRACTION-2 Phase 2 clinical trial of GFB-887, a highly potent and selective inhibitor of the Transient Receptor Potential Canonical Channel 5 (TRPC5)1. Scheduled to enroll approximately 35 patients, the extension study is designed to assess the long-term safety and tolerability of GFB-887.

“I am delighted that our understanding of the molecular drivers of kidney disease and our ability to identify associated targets and patient subsets now enables the pursuit of experimental precision kidney drugs like GFB-887,” said Katherine Tuttle , MD, FASN, FACP, FNKF, executive director of research at Providence Health Care and professor of medicine at the University of Washington and investigator in the TRACTION-2 trial. “Overactivation of the TRPC5-Rac1 pathway is implicated in the pathogenesis of kidney disease in a large number of patients with FSGS. I look forward to seeing how GFB-887 inhibition of TRPC5 translates clinically, with the potential for short-term reduction in proteinuria and long-term, sustainable benefit to patients. “

Anthony Johnson, MD, President and CEO of Goldfinch Bio said, “The launch of the open label extension study TRACTION-2 is another important milestone as we advance GFB-887 as a drug. precision potential to meet the significant unmet need of patients with FSGS and other kidney diseases. We thank the researchers of TRACTION-2 and the extension study, the clinical research staff and, most importantly, the patients who participated in these important studies. By working together, I believe we can make precision kidney drugs a much needed new therapeutic solution for people living with kidney disease. “

Currently, patients with kidney disease, including FSGS, have limited treatment options, which are often associated with difficult short-term and long-term side effects. Many patients eventually require dialysis and kidney transplants, including repeat transplants due to the recurrence of the disease. Goldfinch Bio is advancing a pipeline of precision drugs designed to target the underlying causes of kidney disease, with the ultimate vision of saving the kidneys and ending dialysis.

About TRACTION-2 and the Open-Label Extension Study

TRACTION-2 is a phase 2, multicenter, double-blind, randomized, placebo-controlled trial evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GFB-887 in approximately 125 patients with FSGS, TR-MCD or diabetic nephropathy (DN). The primary objective of the study is to evaluate the clinical activity of multiple doses of GFB-887 over 12 weeks, as measured by the percentage change from baseline of the urinary protein / creatinine ratio, of the ratio urine albumin / creatinine and 24 hour urine protein / creatinine ratio. albumin excretion. Secondary outcome measures include the safety and tolerability and pharmacokinetics of multiple doses of GFB-887. Additional exploratory outcome measures will include changes from baseline in PD biomarkers associated with TRPC5-Rac1 activation.

FSGS patients in the open-label extension study will be included in the ongoing Phase 2 TRACTION-2 multiple-dose escalating trial. Patients will have follow-up visits at weeks 12, 24, 36, 48, and every 24 weeks thereafter for approximately three years from the time of their first dose in the open-label extension study to assess safety long-term and sustainability of the response.

Goldfinch plans to release initial clinical data for TRACTION-2 in the first quarter of 2022. For more information about the clinical trial, please visit: www.clinicaltrials.gov (TRACTION-2: NCT04387448; Open-Label Extension: NCT04950114).

About GFB-887

GFB-887 is a once-daily oral TRPC5 ion channel inhibitor in clinical development for the treatment of kidney disease including FSGS, TR-MCD and DN. TRPC5 is a calcium permeable ion channel involved in the pathogenesis of kidney disease. Recent evidence has shown that TRPC5 and Rac1, an essential regulator of cell motility, form a vicious cycle that results in pathogenic remodeling of the actin cytoskeleton in podocytes. Overactivation of the TRPC5-Rac1 pathway causes loss of podocytes and disruption of the filtration barrier, leading to proteinuria, characteristic of progressive kidney diseases such as FSGS and DN. Inhibition of TRPC5 and subsequent suppression of the overactivated TRPC5-Rac1 pathway offers a potential point of therapeutic intervention to restore podocyte integrity and arrest the progression of these diseases. In a phase 1 clinical trial, GFB-887 was well tolerated and dose-dependent increases in drug exposure from GFB-887 were observed.

About Chardonneret Bio

Goldfinch Bio, Inc. is a clinical-stage biotechnology company focused on providing precision disease-modifying drugs that bring hope and a renewed quality of life to people with kidney disease. We aspire to save the kidneys and end dialysis. Our precision medicine product engine enables us to discover and validate novel targets to understand molecular and phenotypic heterogeneity in diverse patient populations with renal failure in order to identify the subsets most likely to respond to our treatments. We have a strong portfolio of new precision medicine product candidates targeting kidney disease with significant unmet need, including two clinically active ingredients. In 2020, Goldfinch Bio was named one of Fierce Biotech’s “Fierce 15” companies. Visit us at www.goldfinchbio.com to find out more.

1 Patients diagnosed with treatment-resistant minimal change disease (TR-MCD), which is considered a subset of FSGS, are also being enrolled in the open-label phase 2 extension study. The TRACTION-2 phase 2 trial is recruiting patients with FSGS, TR-MCD and diabetic nephropathy.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20210810005307/en/

Contacts

Investors:
Hannah deresiewicz
Stern Investor Relations, Inc.
212-362-1200
[email protected]

Media:
Liz melone
[email protected]


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