pp-122 Capsules 50 mg
Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Indication: Moderate-to-severe ulcerative colitis (adults); Crohn's disease (Phase 3 entry planned 2026)
Clinical stage: Phase 3
Modality: Small molecule (RNA splicing modulator)
Mechanism / Target: Binds hnRNP A1; promotes retention of intron 7 in CCL17 pre-mRNA; modulates NF-κB signalling reducing pro-inflammatory cytokines (TNF-α, IL-6, IL-8)
Route / form: Oral capsule (50 mg once daily)
Differentiation: First-in-class RNA splicing modulator for IBD; durable mucosal healing demonstrated in Phase 2b; no classical immunosuppression-related safety risks; once-daily oral dosing;
Manufacturer #39160
Clinical-stage biopharmaceutical focused on chronic inflammatory diseases. Develops first-in-class RNA splicing modulators targeting unmet needs in IBD. Pursuing global regulatory strategy with no co-development partner.
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