SynAct Pharma has completed enrolling patients in a Phase IIb EXPAND clinical trial of AP1189 for the treatment of early rheumatoid arthritis (RA) patients with severe disease activity.
The EXPAND is a continuation of BEGIN study, which demonstrated a fast and clinical meaningful reduction in the patient’s disease activity using AP1189 against placebo treatment following four weeks of treatment.
Previously treated naive patients with severe RA will receive AP1189 in combination with first-line treatment Methotrexate in the multicentre, randomised, double-blind, placebo-controlled EXPAND study.
Being designed as a once daily dosage form, AP1189 tablet formulation will be dosed for 12 weeks to a total of 127 randomised patients.
SynAct Pharma CSO Thomas Jonassen said: “It’s satisfying to announce that the last patient in the EXPAND study was enroled well ahead of schedule.
“We now look forward to completing the dosing and reporting the study,” Jonassen added.
Dosing of the patients with AP1189 is expected to be completed in this July, while the last patient’s safety follow-up visit will be carried out in August.
The company is planning to announce the top-line study data in approximately five months.
AP1189, which reduces inflammation, is said to circumvent the safety issues related to suppression of the immune system against other therapies.