Resomelagon Phase-2B ADVANCE Study Update: 190 Patients Randomized Tracking for Year-End Recruitment Completion
SynAct Pharma AB (publ) (”SynAct”) (Nasdaq Stockholm: SYNACT), a clinical-stage biotechnological company focused on treating inflammation through resolution therapy, has randomized 190 out of 240 patients and is on-track on lead program Phase 2b study.
“Since summer we have established good momentum in recruitment,” said Thomas Jonassen, Chief Science Officer of SynAct Pharma.
The Phase 2b ADVANCE is a 12-week randomized placebo-controlled study including newly diagnosed patients with Rheumatoid Arthritis, with elevated inflammation levels (CRP levels above 3mg/l), severe disease symptoms, and ready to initiate 1st line methotrexate therapy.
Thomas Jonassen continues, “Rheumatoid Arthritis affects 18 million people and is expected to affect up to 32 million people by 2050 (ref. 1). About 50% of patients present with moderate to severe disease scores at time of diagnosis (ref. 2) and major medical societies recommend progressive treatment to prevent disease from progressing. Resomelagon in addition to 1st line methotrexate therapy may be a safe and effective way to reduce disease symptoms and may prolong or prevent the need for additional therapy typically adding glucocoid steriods and biologic DMARDS.”
References: 1) Lancet Rheumatol 2023;5: e594–610; 2) Z Rheumatol. 2017 Jun;76(5):434-442