pp-169 Suspension for infusion
Dossier type
CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Indication: Recessive dystrophic epidermolysis bullosa (RDEB) — rare COL7A1 mutation-driven blistering skin disease
Clinical stage: Phase 3 — EB-01 trial ongoing
Modality: Cell therapy (allogeneic ABCB5+ skin-derived mesenchymal stromal cells; off-the-shelf)
Mechanism / Target: ABCB5+ MSCs produce anti-inflammatory cytokines (IL-10, TGF-β), suppress T-cell activation and stimulate wound healing; reduce blistering and improve skin integrity in RDEB
Route / form: Intravenous infusion (repeat dosing)
Differentiation: Allogeneic off-the-shelf design (no patient manufacturing); ABCB5+ selection enriches potent immunomodulatory subset; showed wound healing benefit in Phase 2; addresses high unmet need in RDEB
Manufacturer #39193
Clinical-stage cell therapy company specialising in ABCB5-positive mesenchymal stromal cells. Develops allogeneic off-the-shelf MSC therapies for rare, chronic wounds and skin diseases. Wholly owned EU-GMP-compliant manufacturing and Phase 3 pipeline in rare dermatological conditions.
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