SynAct Pharma has announced that an independent Data Safety Monitoring Board (DSMB) has reviewed unblinded and validated data from part 1 of the company’s Phase 2a study in patients with rheumatoid arthritis (RA) with high disease activity with the aim to recommend which dose(s) of AP1189 to be brought into part 2 of the study.
The DSMB is composed of independent clinical experts and has the responsibility to recommend further dosing and continuation of the study. The company remains blinded to the data.
“We are very excited that DSMB observes good safety and promising signals of efficacy in the interim analysis of AP1189 in patients with severe and newly diagnosed rheumatoid arthritis. This may indicate that we might see a clinical effect already following 4 weeks of treatment. We look forward to initiate recruitment in part 2 of the study this week. As we are testing newly diagnosed patients, we have decided to name this study BEGIN,” says Thomas Jonassen, CSO, SynAct Pharma.
The BEGIN study
The BEGIN study is designed as a placebo-controlled double-blind multicenter study with a 2:1 randomization ratio of once-daily dosing of AP1189 vs placebo in RA patients referred to rheumatological departments due to uncontrolled disease activity defined as a Clinical Disease Activity Index (CDAI) score higher than 22. AP1189 or placebo is dosed once daily for 4 weeks in parallel with the initiation of a treatment with the disease-modulating, anti-rheumatic drug methotrexate (MTX). The full study consisting of part 1 and 2 will include up to 90 patients. The second part of the study will be initiated this week according to the DSMB recommendation.
The data analysis conducted on the first 26 patients who has completed treatment indicates that AP1189 is safe and well tolerated at the current dose schedule. There are no reports of any serious adverse events. The overall frequency of adverse events is similar in the two treatment groups, and slightly higher than the placebo group. The most common adverse event was nausea.
Photo of Jeppe Øvlesen, CEO, SynAct Pharma