Business reasons

This is a phase 2a study evaluating the safety and tolerability of multiple ascending doses of GFB-887 in patients with diabetic nephropathy (DN), focal segmental glomerulosclerosis (FSGS), and treatment-resistant minimal change disease (TR-MCD).

Approximately 125 patients will be enrolled in this study across the United States. Patients with DN and FSGS/TR-MCD will be randomized in 3 ascending dose cohorts to receive either GFB-887 or placebo.

Inclusion Criteria:

• All patients:

  1. Male or female 18-75 years of age, of any race, at the time of signing informed consent.
  2. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 at Screening.
  3. Currently receiving an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).

• For DN patients:

  1. Diagnosis of type 2 diabetes with glycated hemoglobin (HbA1c) level ≤11% at Screening.
  2. UACR ≥ 150 mg/g.

• For FSGS/TR-MCD patients:

  1. Diagnosis of FSGS based on either biopsy or genetic testing or TR-MCD based on biopsy.
  2. UPCR ≥ 1.0 g/g.

Exclusion Criteria:

• All patients:

  1. Evidence of another (non-DN, non-FSGS/TR-MCD, respectively) kidney disease.
  2. History of malignancy, unless in remission for at least 5 years other than adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer not expected to require treatment over the course of the study.
  3. History of any organ or bone marrow transplant, including kidney grafts.
  4. History of alcoholism or drug/chemical abuse within 12 months prior to Screening.

• For DN patients:

  1. Renal disease that requires immunosuppressive therapy (currently, or in the past).
  2. Body mass index (BMI) >45 kg/m2.

• For FSGS/TR-MCD patients:

  1. Currently on calcineurin inhibitors or history of resistance to calcineurin inhibitors.
  2. Body mass index (BMI) >40 kg/m2.
  3. Known history of severe or chronic hepatobiliary disease.