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 announced that it will present initial data from its Phase 1 clinical trial of GFB-024 in a poster presentation at the American Diabetes Association (ADA) 82nd Scientific Sessions, taking place June 3-7 in New Orleans, LA, and an oral presentation at the Endocrine Society’s Annual Meeting, ENDO 2022, taking place June 11-14 in Atlanta, GA. Both meetings also have a virtual component.
Goldfinch Bio is developing GFB-024, a peripherally restricted cannabinoid 1 (CB1) inverse agonist monoclonal antibody, for patients with severe insulin resistant diabetic nephropathy (SIRDN) and CB1 pathway overactivation. Patients who present with severe insulin-resistant diabetes (SIRD) have a rapidly progressing form of DN and are at particularly high risk of developing diabetic kidney disease and progression to kidney failure. In addition, elevated CB1 signaling has been shown to induce podocyte death, proteinuria and tubular cellular injury, resulting in serious harm to the kidney.
GFB-024 has the potential to provide disease-modifying effects in the kidney while treating the underlying metabolic dysfunction in obese patients without the CNS side-effects seen by prior small molecule CB1 antagonists. GFB-024 has demonstrated podocyte protective effects in preclinical models, while clinical data from first generation CB1 antagonists have demonstrated metabolic benefits, such as reduced cholesterol, glucose, and HbA1c, in third-party clinical trials, which may also lead to additional beneficial kidney effects.
The double-blind, randomized, placebo-controlled Phase 1 trial is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-ascending doses of GFB-024 in overweight and obese healthy volunteers, as well as to explore candidate predictive biomarkers to confirm peripheral CB1 target engagement to identify patients most likely to respond to GFB-024 and provide early central nervous system (CNS) safety derisking. The study also includes a cohort evaluating repeat dosing of GFB-024 in subjects with type 2 diabetes mellitus, in order to assess immunogenicity, multiple dose PK and safety.
Details of the presentations are as follows:
Poster Presentation at the ADA 82nd Scientific Sessions, June 6, 2022
Presentation Title: Phase 1, Randomized, Controlled Trial of GFB-024, a Once-Monthly CB1 Inverse Agonist, in Healthy Overweight and Obese Participants and in Participants with Type 2 Diabetes Mellitus
Session Date and Time: Monday, June 6, 2022 from 12:00-1:00 p.m. CT (1:00-2:00 p.m. ET)
Location: New Orleans Ernest N. Morial Convention Center, Hall D-E
Oral Presentation at ENDO 2022, June 11, 2022
Presentation Title: Phase 1, Randomized, Controlled Trial of GFB-024, a Once-Monthly CB1 Inverse Agonist, in Healthy Overweight and Obese Participants and in Participants with Type 2 Diabetes Mellitus
Session Date and Time: Saturday, June 11, 2022 from 11:30 a.m.-1:00 p.m. ET
Location: Georgia World Congress Center, A404-A405
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. Visit us at www.goldfinchbio.com to learn more.
