Goldfinch Bio Showcases Biology, Genetic and Clinical Programs at ASN Kidney Week Demonstrating Leadership in Precision Medicines for Kidney Diseases

— Interim data readout expected mid-2022 for the Company’s ongoing Phase 2 TRACTION-2 trial evaluating GFB-887 in patients with FSGS and DN; TRACTION-2 trial design, including interim analysis plan, presented at ASN —

— Five additional presentations at ASN demonstrate breadth and depth of Goldfinch Bio’s biology and genetic research efforts to advance precision medicines for kidney disease —

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Goldfinch Bio, a clinical stage biotechnology company focused on discovering and developing precision medicines for the treatment of kidney diseases, today provided an update on TRACTION-2, its ongoing Phase 2 clinical trial evaluating GFB-887 for the treatment of focal segmental glomerulosclerosis (FSGS) and diabetic nephropathy (DN). The update coincides with Goldfinch Bio’s presentation of the TRACTION-2 trial design at the American Society of Nephrology’s (ASN) Kidney Week, held virtually from November 4-7, 2021.

“We’re pleased to share an update on the TRACTION-2 trial evaluating our lead program GFB-887 for the treatment of FSGS and DN. In the face of COVID-19 related challenges, which led to slower-than-anticipated patient accrual early in the trial, our team has worked diligently to expand to additional sites and coordinate closely with study investigators and clinical research staff,” said Anthony Johnson, M.D., President and Chief Executive Officer of Goldfinch Bio. “We are encouraged by the high level of physician and patient enthusiasm around the trial, and I’m happy to report that we’ve seen a steady increase in enrollment and anticipate reporting interim data in mid-2022. This will be an important step as we continue to advance this promising and potentially disease-modifying therapy for people living with kidney diseases.”

TRACTION-2 Trial Design

As outlined in the ASN poster presentation, the primary objective of the TRACTION-2 trial is to evaluate the clinical activity of multiple doses of GFB-887 in approximately 78 patients treated for 12 weeks, as measured by percent change from baseline in urine protein to creatine ratio (UPCR) in patients with FSGS, or percent change from baseline in urine albumin to creatine ratios (UACR) in patients with DN. The U.S. Food and Drug Administration (FDA) has indicated that reduction in proteinuria is an approvable endpoint under the subpart H accelerated approval pathway for investigational kidney therapeutics, including for FSGS. Secondary outcome measures of TRACTION-2 include safety and tolerability and pharmacokinetics of multiple doses of GFB-887, as well as remission status in FSGS patients. Key exploratory endpoints include an assessment of the association between urinary Rac1 – a potential patient selection biomarker – and efficacy, as well as changes in health-related quality of life scores and the nephrotic syndrome edema-clinician rating scale.

Goldfinch Bio plans to conduct an interim analysis after approximately two-thirds of patients have completed treatment at the highest dose cohorts. Results from the interim analysis will determine whether TRACTION-2 should continue as planned, additional patients should be enrolled to increase the total sample size to improve conditional power, or the biomarker population should be further enriched. Goldfinch Bio is on track to complete patient accrual sufficient to reach the interim analysis and expects to report data in mid-2022.

“I am pleased to be participating in this trial, and excited to see Goldfinch Bio leverage the growing understanding of molecular drivers of kidney disease to advance GFB-887 as a novel therapeutic to potentially improve outcomes for patients whose disease is driven by TRPC5 pathway overactivation,” Katherine Tuttle, M.D., FASN, FACP, FNKF, Executive Director for Research at Providence Health Care and Professor of Medicine at the University of Washington and investigator in the TRACTION-2 trial. “I believe the design of TRACTION-2 will enable us to glean insights into GFB-887’s ability to reduce proteinuria and, subsequently, help patients preserve their native kidney function. I look forward to reviewing interim data from the trial next year.”

In addition to the poster on the TRACTION-2 trial design, Goldfinch Bio presented five posters showcasing development efforts across its clinical, genetics and biology programs, including its proprietary Kidney Genome Atlas and podocyte and organoid platform, which are the key foundational elements of the Company’s product engine. These presentations are now available on the “Publications & Presentations” page of Goldfinch Bio’s website, accessible here.

About Goldfinch Bio

Goldfinch Bio, Inc. is a clinical stage biotechnology company focused on delivering disease-modifying precision medicines that bring hope and renewed quality of life to people living with kidney diseases. We aspire to save kidneys and end dialysis. Our precision medicine product engine allows us to discover, validate and drug novel targets that may allow us to better treat subsets of patients, within a heterogeneous kidney disease, based on common characteristics. We have a robust pipeline of novel, precision medicine product candidates targeting kidney diseases with significant unmet need, including two clinical-stage assets. In 2020, Goldfinch Bio was named one of Fierce Biotech’s “Fierce 15” companies. Visit us at www.goldfinchbio.com to learn more.

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