drugset / Press release

Resomelagon Phase-2B ADVANCE Study Update: 190 Patients Randomized Tracking for Year-End Recruitment Completion

2025-11-03 · SynAct Pharma Aps · original synactpharma.com ↗

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 1 st 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 1 st 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 For further information, please contact: Jeppe Øvlesen CEO, SynAct Pharma AB Phone: + 45 2844 7567 E-mail: [email protected] About SynAct Pharma AB SynAct Pharma AB (Nasdaq Stockholm: SYNACT) is a clinical stage biotechnology company focused on the resolution of inflammation through the selective activation of the melanocortin system. The company has a broad portfolio of oral and injectable selective melanocortin agonists aimed at inducing anti-inflammatory and inflammation resolution activity to help patients achieve immune balance and overcome their inflammation. For further information: https://www.synactpharma.com/ . Attachments Resomelagon Phase-2B ADVANCE Study Update: 190 Patients Randomized Tracking for Year-End Recruitment Completion

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