CTA approved for the Phase 2b study EXPAND

SynAct Pharma AB (publ) (“SynAct”) today announced that the Clinical Trial Application (CTA) to initiate the clinical Phase 2b study, EXPAND, with the Company’s candidate drug, AP1189, in patients with newly diagnosed rheumatoid arthritis (RA) has been approved in Moldova with the aim to start recruitment of patients as soon as the study sites has been initiated in September. Approval in Bulgaria is expected in the weeks to come.

EXPAND is part of SynAct’s strategy to further develop AP1189 as a new oral treatment option in RA. The study is designed to identify the full treatment potential of the compound given in combination with methotrexate (MTX) in previously treatment naïve patients with high disease activity.

“This is a major achievement for SynAct to mature our clinical program further and to bring AP1189 into Phase 2b. I am pleased that the SynAct team and our collaborators are delivering according to the ambitious plans we have laid out and communicated. A positive outcome of the study, planned to be completed in second half of 2023 will provide state-of the art data to demonstrate AP1189 as a very attractive asset, that can be benchmarked directly against other treatments in RA”, says Jeppe Øvlesen, CEO of SynAct Pharma.

The purpose of the EXPAND study is to confirm the encouraging effects of AP1189 demonstrated in the BEGIN study, where 100 mg AP1189 once daily for four weeks in combination with MTX treatment was found to be safe and well tolerated and met the primary endpoint of a significantly greater than placebo reduction in clinical disease activity (reduction in CDAI; Placebo: 9.3 points vs 100 mg AP1189: 15.5 points, P<0.05). In addition, treatment with AP1189 was associated with a statistically significant higher proportion of patients achieving 20% improvement in American College of Rheumatology (ACR20) score. (ACR20; Placebo: 33% vs 100 mg AP1189: 61%, P<0.05).

The information was submitted, through the agency of the contact person below, for publication at 07:00 a.m. CEST on August 25, 2022.