The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetic profile of GFB-887 in healthy volunteers and in patients with chronic kidney disease. Topline safety data from healthy volunteers are expected by year-end 2019.
“This Phase 1 study will inform the future clinical development path of GFB-887, a targeted podocyte-protective therapy in development for patients with rare glomerular diseases with high unmet need, as well as patients with DN, the leading cause of end-stage kidney disease,” said Tony Johnson, M.D., Goldfinch’s President and Chief Executive Officer. “Initiation of this clinical program is supported by preclinical data recently presented by Goldfinch demonstrating the potential of GFB-887 to ameliorate proteinuric kidney disease through the inhibition of the TRPC5-Rac1 pathway.”
The Phase 1 study will be conducted in two parts. Part 1 comprises a single-ascending dose (SAD) escalation component and a food effect component in healthy volunteers, and Part 2 comprises a multiple ascending dose (MAD) component in healthy volunteers. The Phase 1 program will also include a study in renally-impaired patients. Primary study objectives include evaluating the safety, tolerability and pharmacokinetic (PK) profile of single and multiple doses of GFB-887. Secondary objectives include evaluating the safety, tolerability and PK of GFB-887 in patients with renal impairment.
Source: Company Press Release