SynAct Pharma´s clinical trial application for AP1189 in Nephrotic Syndrome approved by the Danish Medical Agency
SynAct Pharma AB ("SynAct") today announced that the Danish Medical Agency has approved the company’s clinical trial application (CTA) for a Phase IIa study in idiopathic membranous nephropathy patients with Nephrotic Syndrome.In the Phase IIa study, AP1189 will be tested in a double-blind, placebo-controlled multicentre study as add-on therapy to ACE-inhibitor or Angiotensin-2 receptor antagonists in a once-daily dose regimen for four weeks with the primary purpose to show treatment effect on urinary protein excretion relative to pre-treatment levels and placebo. The patients will be dosed