Approval of amended study protocol for the Phase 2a study in iMN

SynAct Pharma AB (publ) (“SynAct”) today announced that the protocol amendment of the ongoing SynAct-CS003 study with the Company’s candidate drug AP1189 in idiopathic membranous nephropathy (iMN) patients with severe proteinuria and/or Nephrotic Syndrome (NS) has been approved.

SynAct wants to explore the opportunity to treat iMN patients for up to 3 months with AP1189 tablets. Therefore, and as previously communicated, the Company submitted a major amendment to the study protocol in July 2022, which has now been approved by the Danish Medicines Agency and is being assessed in Sweden and Norway.

“AP1189 is enabling resolution of inflammation and we believe that it can be a beneficial treatment option in kidney diseases, such as iMN, where there is a significant medical need for new effective and well tolerated treatments. Together with our investigators, we are ready to continue this study according to the improved protocol and investigate the potential of AP1189” said Thomas Jonassen, CSO SynAct Pharma.

SynAct aims to enroll a minimum of 18 patients to the study and expect to complete and report key results during 2023.

The information was submitted, through the agency of the contact person below, for publication at 07:00 a.m. CEST on September 14, 2022.