SynAct Pharma initiates dosing in the RESOLVE study in DMARD-IR RA

SynAct Pharma AB (publ) (“SynAct”) today announced that the first patient was dosed in part A of the clinical Phase 2a/b study RESOLVE with the company’s candidate drug, AP1189, in rheumatoid arthritis (RA) patients with inadequate response to disease‐modifying antirheumatic drugs (DMARD-IR).

The RESOLVE study, aimed at evaluating the safety and efficacy of SynAct´s lead compound, AP1189, is now initiated according to plan with dosing of the first patient. The study is conducted under an US Investigational New Drug (IND) Application at 17 sites in the US, Bulgaria, and Moldova.

“To initiate dosing in the RESOLVE study is a major milestone for the project. AP1189 addresses an unmet need for a novel treatment option in RA as the compound compared to most current treatment options is aimed to promote immunological resolution. This novel concept could have a major impact on the treatment of RA, where more than 40 % of all patients don’t respond adequately to first line treatment” said Thomas Jonassen, CSO. “We are looking forward to seeing the results in the second half of 2023, if recruitment goes as planned.”

The AP1189 compound is currently tested in a parallel running Phase 2b study in previous treatment naïve RA patients with high disease activity, the EXPAND study. This study is to be considered as a continuation of the BEGIN study, where AP1189 was found to be safe and well tolerated and induced a statistically significant reduction in disease activity when given once daily for 4 weeks.

The information was submitted, through the agency of the contact persons set out below, for publication at 07:00 CET on December 16, 2022.