ZyVersa Therapeutics (ZVSA) announces that the Clinical Advancement Center, PLLC in San Antonio, Texas is the first clinical site activated and ready for patient recruitment in our VAR 200 Phase 2a clinical study in patients with DKD. The lead investigator is Pablo Pergola, MD, PhD. VAR 200’s proof-of-concept Phase 2a study will be conducted at one to two US sites and will enroll an adequate number of subjects to complete eight. It is a 16-week open-label study to evaluate the drug’s efficacy and safety in patients with type 2 diabetes and diabetic kidney disease with proteinuria. VAR 200 will be administered intravenously twice weekly at a single dose and will be added to the stable drug regimen used by each patient. The primary efficacy endpoint is percent change from baseline to week 12 in urinary albumin to creatinine ratio.
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