regulatory
confidence high
sentiment positive
materiality 0.65
Chemomab receives FDA clearance to start Phase 2 trial of CM-101 in systemic sclerosis
Chemomab Therapeutics Ltd.
- FDA cleared IND for Phase 2 ABATE trial of CM-101 in systemic sclerosis (SSc).
- CM-101 is a first-in-class monoclonal antibody targeting CCL24; has Orphan Drug designation for SSc and PSC.
- Trial to enroll 45 patients; primary endpoint safety; top-line data expected H2 2024.
- CM-101 previously well-tolerated in early trials, reduced fibro-inflammatory biomarkers.