AP1189 is used for the treatment of early rheumatoid arthritis patients with severe disease activity. Credit: David Richfield / commons.wikimedia.org.

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.

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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.

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“We now look forward to completing the dosing and reporting the study,” Jonassen added.

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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.