Chronic kidney disease (CKD), also known as chronic renal disease, is a progressive loss in renal function over a period of months or years. Professional guidelines classify the severity of CKD in five stages, with stage 1 being the mildest and usually causing few symptoms and stage 5 being a severe illness with poor life expectancy if untreated. Stage 5 CKD is often called end-stage kidney disease, end-stage renal disease, or end-stage kidney failure, and is largely synonymous with the now outdated terms chronic renal failure or chronic kidney failure; and usually means the patient requires renal replacement therapy, which may involve a form of dialysis, but ideally constitutes a kidney transplant.
Prevalence of CKD in the US:
Twenty six million patients in the U.S. alone are diagnosed with chronic kidney diseases (“CKD”). Patients with severe CKD stages (3 and 4) suffer from a gradual and accelerated loss of their renal function (end stage renal disease or ESRD) leading to the need for maintenance dialysis or kidney transplant.
Development Stage of Clinical Trial:
PBI-4050 has completed a randomized, double-blind, placebo-controlled, multi-dose phase Ib study to demonstrate the safety and tolerability of PBI-4050, and to determine the pharmacokinetic profile of PBI-4050 following multiple oral doses over 10 days in patients with stage 3b or 4 stable renal impairment. The trial was conducted in 8 patients with 6 patients receiving PBI-4050 and 2 patients receiving matching placebo.
The Corporation plans to enter into partnerships for other larger medical indications and or geographical regions requiring a much more substantial local commercial reach and resources. It is generally not Prometic’s intention to independently undertake late-stage clinical trials (phase 3) in large indications, such as Idiopathic Pulmonary Fibrosis (“IPF”), Chronic Kidney Disease (“CKD”) or Diabetic Kidney Disease (“DKD”) without the support of a strategic venture or big pharma partner.