SynAct Pharma AB (publ) (“SynAct”) today announced that it has completed patient recruitment to the company’s Phase 2b 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 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.
Key results focusing on the primary efficacy readout (ACR20), secondary read outs (ACR50, ACR70; reduction in CDAI and DAS28) as well as safety will be presented in a press release followed by an investor call when the data are available. The company will continue to update the market on the further progress and the process to finalize the EXPAND study.
Ongoing safety challenges with key classes of RA therapeutics underscore the need for new treatment modalities. AP1189 promotes inflammatory resolution, a very promising approach to circumvent the safety issues related to suppression of the immune system encountered with other therapies.