SynAct Pharma AB (“SynAct”) today announced that the company has submitted a clinical trial application (CTA) to the Danish Medicines Agency to initiate a Phase IIa study with its lead candidate drug AP1189 in Idiopathic Membranous Nephropathy (IMN). IMN is the single most common cause of Nephrotic Syndrome in adults.
In the Phase IIa study, AP1189 will be tested in a double-blind, placebo-controlled multicenter study as add-on therapy to ACE-inh or A2R-ant treatment in a once-daily dose regimen for four weeks with the primary endpoint to show treatment effect on urinary protein excretion relative to pre-treatment levels and placebo.
IMN is the single most common cause of Nephrotic Syndrome in adults and is typically characterized by high levels of protein in the urine, edema, hypoalbuminemia and elevated plasma lipids. When the disease is not controlled in patients the likelihood to develop chronic kidney disease is high.
The first-line treatment of IMN is Angiotensin-converting-enzyme inhibitors (ACE-inh) or Angiotensin II receptor blockers (A2IR-ant) to control blood pressure and decrease the protein loss in the urine. If continued symptoms follow in six months, the patient is treated with glucocorticoids or immunosuppressives. The company has decided to file the application knowing that, until further, the review from both Health Authorities and Ethical Committee can be expected to be significantly delayed due to the extraordinary situation related to the COVID-19 pandemic. SynAct will return with further updated timelines related to the study once the approval has been given by the authorities.
This information is such information that SynAct Pharma AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted, through the agency of the above contact person, for publication on March 31, 2020.
For further information about SynAct Pharma AB, please contact:
Jeppe Øvlesen Thomas Jonassen
CEO, SynAct Pharma AB CSO, SynAct Pharma AB
Phone: +45 28 44 75 67 Phone: +45 40 15 66 69
Mail: [email protected] Mail: tj@synactpharma.com