SynAct Pharma has announced evaluation of the 4-week RESOLVE Phase 2a clinical trial in moderate to severely active rheumatoid arthritis patients with an incomplete response to methotrexate.
During the evaluation of the unblinded study data SynAct Pharma identified multiple issues that need further investigation before any conclusion on the outcome of the study can be made, the company states. The RESOLVE study was designed to identify doses of resomelagon (AP1189) to be applied in part B of the trial and as an initial assessment of safety and tolerability in patients with moderate to severely active rheumatoid arthritis with an incomplete response to methotrexate (MTX). The study conducted under an US-IND at sites in the US, Moldova and Bulgaria and tested 3 doses of resomelagon vs placebo; a total of 125 patients were randomized and the study was conducted though a contracted full-service CRO.
“We are disappointed with the issues we have encountered in attempting to assess the RESOLVE study,” stated Torbjörn Bjerke, CEO of SynAct Pharma. “We have informed the clinical CRO that we will be initiating a third-party audit.”
SynAct Pharma has decided to initiate a full third-party investigation into the conduct and quality of the trial including a full study audit. The audit will also include the EXPAND study as the previously announced trial was run by the same CRO with an overlap in clinical sites. SynAct Pharma will further inform the market when the full investigation of the study has been finalized which it anticipates will be available in the beginning of 2024, it states.
Photo of Torbjørn Bjerke: SynAct