SynAct Pharma AB (“SynAct”) today announced that recruitment in the BEGIN study in Rheumatoid Arthritis (RA) has been extended into the first half of September in order to reach the goal of 105 randomized patients, of which 98 have been recruited to date. As a result of the continued recruitment, reporting of key results previously expected to take place by the end of Q3 will be postponed to early Q4 after which a press release with top-line results will be released immediately. SynAct applauds the efforts of its clinical sites and their patients to keep this important evaluation of AP1189 going strong despite the global challenges on clinical trial recruitment caused by the ongoing pandemic.
“During the spring we decided to increase the study size to increase the likelihood of showing statistical significance of AP1189 treatment relative to placebo. Recruitment was strong over the summer months and we are excited that the last few patients needed to reach our goal are now identified and will be enrolled into the study in the coming weeks,” said Thomas Jonassen CSO of SynAct Pharma. “In parallel with the completion of the recruitment, an abstract as reported August 20th was selected for presentation on November 9th at the American College of Rheumatology (ACR) Convergence 2021 medical congress. The presentation will focus on the AP1189 compound’s clinical pharmacology as well as clinical efficacy and it is expected that it will be possible to include high level data from the BEGIN study.”
The BEGIN study is setup as a randomized, placebo-controlled study evaluating two doses of AP1189 (50 and 100 mg given orally once daily) for four weeks against placebo as add-on therapy to methotrexate in patients with severe active rheumatoid arthritis. The primary efficacy endpoint in the study is reduction in disease activity from severe (defined as clinical disease activity >22) to moderate or low disease activity within the four-week treatment period. Interim data based on the evaluation of the first 26 patients demonstrate that 75% of patients treated with 100 mg and 67% of patients treated with 50 mg AP1189 reached the primary readout compared to 44% of the placebo treated patients within 4 weeks of treatment.
The information was submitted, through the agency of the contact person below, for publication on August 27, 2021
For further information about SynAct Pharma AB, please contact:
Jeppe Øvlesen Thomas Jonassen
CEO, SynAct Pharma AB CSO, SynAct Pharma AB
Phone: +45 28 44 75 67 Phone: +45 40 15 66 69
Mail: [email protected] Mail: [email protected]