SynAct Pharma has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA), with the aim to commence its Phase 2a/b clinical trial RESOLVE with AP1189 in the United States.
“We are happy to announce that we have now submitted the IND to the FDA in line with our previously communicated plans. The US market represents the largest commercial opportunity for AP1189 in Rheumatoid Arthritis (RA). The inclusion of the US adds to the attractiveness of AP1189 in our discussions with potential business partners,” said Jeppe Øvlesen, CEO of SynAct Pharma.
The RESOLVE trial
The RESOLVE study is a randomized, placebo-controlled, double-blinded, two-part Phase 2a/b clinical study, testing daily treatment of AP1189 in patients with an incomplete response to first-line disease modifying antirheumatic drugs (DMARD), who are experiencing moderate to severe disease activity.
A large percentage of patients treated with DMARDs never achieve the full desired effect, describes the company in its press release. Also, they have a diminishing treatment effect or suffer from side effects that can prevent further treatment. These patients who experience an inadequate response to DMARDs are referred to as DMARD-IR (inadequate responder). The company believes that AP1189 could be very well suited for DMARD-IR patients given the emerging profile of an efficacious, safe, and well tolerated once-daily oral therapy.
In parallel with the IND application, Clinical Trial Applications (CTAs) are filed in Europe. Subject to regulatory approval from the authorities, the study will be initiated in Q4 2022, with the aim of presenting data from the first part in the second half of 2023.
Photo of Jeppe Øvlesen: SynAct Pharma