Goldfinch Bio, Inc., a biotechnology firm developing precision therapies for kidney disease patients, has reportedly started dosing in its Phase 1 clinical trial assessing GFB-887. The firm’s selective and sub-type specific small molecule TRPC5 inhibitor, GFB-887, is being evaluated as a possible treatment for kidney diseases linked with progressive renal dysfunction and proteinuria comprising treatment-resistant minimal change disease (TR-MCD), focal segmental glomerulosclerosis (FSGS) and diabetic nephropathy (DN).

As per trusted sources, the study will evaluate the drug based on tolerability, safety, and pharmacokinetic profile among healthy volunteers and in patients suffering from chronic kidney disease.

Tony Johnson, M.D., President and CEO of Goldfinch Bio, said in a statement that the Phase 1 study will determine the future clinical development route of GFB-887, a developing targeted podocyte-protective therapy for patients suffering from rare glomerular diseases with immense unmet need, and patients with DN, which is the main cause of end-stage kidney disease.

Johnson further claimed that the initiation of this clinical trial is backed by Goldfinch’s recently presented preclinical data showcasing the potential of GFB-887 for ameliorating proteinuric kidney disease through the inhibition of the TRPC5-Rac1 pathway.

According to sources familiar with the trial, the Phase 1 study will be performed in two parts. Part 1 will include a single-ascending dose, escalation component, and a food effect component among healthy participants. Part 2 will comprise multiple ascending dose components among healthy participants. The Phase 1 program will also comprise research on renally-impaired patients, reported sources.

Key study objectives include assessment of the tolerability, safety, and pharmacokinetic profile of single and multiple dosages of GFB-887, while the secondary objective of the trial includes the evaluation of tolerability, safety, and pharmacokinetic profile of GFB-887 in patients suffering from renal impairment.

For the record, the GFB-887 clinical program is backed by preclinical data within multiple models of progressive kidney disorders, including data from organoids and podocytes derived from human stem-cell, recently demonstrated at the 2019 ISN World Congress of Nephrology meeting.

Source Credits: https://www.businesswire.com/news/home/20190606005151/en/Goldfinch-Bio-Initiates-Phase-1-Clinical-Trial