SynAct Pharma has completed patient recruitment to the company’s clinical trial EXPAND which is evaluating its lead candidate compound AP1189 in early Rheumatoid Arthritis (RA) patients with severe disease activity.
With all patients included into the study, dosing will be concluded in July and the last patient’s safety follow-up visit to be conducted in August. Top-line data will be reported following clean file and database lock. SynAct therefore anticipates releasing top-line study data in about five months.
“It’s satisfying to announce that the last patient in the EXPAND study was enrolled well ahead of schedule. We now look forward to completing the dosing and reporting the study,” said Thomas Jonassen CSO of SynAct Pharma.
The EXPAND study
The EXPAND study is a continuation of the BEGIN study where SynAct showed AP1189 had the ability to induce a fast and clinical meaningful reduction in the patient’s disease activity compared to placebo treatment already after 4 weeks treatment. In EXPAND, SynAct doses AP1189 in combination with first-line treatment Methotrexate in previously treatment naïve patients with severe RA. A total of 127 have been randomized to be dosed for 12 weeks using the company’s new patient-friendly tablet formulation developed for once daily dosing.