Neovii Advances FDA Fast Track-Designated ATLG Program in Type 1 Diabetes With Pivotal Phase 2 Study - Company Appoints Physician-scientist Salvatore Alesci as Chief Medical Officer
BOSTON, MA and RAPPERSWIL-JONA, SWITZERLAND - October 22, 2026 ( NEWMEDIAWIRE ) - Neovii Pharmaceuticals AG, a Swiss-headquartered, commercial-stage biopharmaceutical company with more than four decades of experience in antibody-based immunotherapies, today announced that it is advancing its Type 1 Diabetes (T1D) clinical program through a company-sponsored pivotal Phase 2 study in the United States and European Union. The international expansion builds on the ongoing investigator-initiated European GIRO (Grafalon in early onset) T1D study and is supported by U.S. Food and Drug Administration (FDA) Fast Track designation for anti-T-lymphocyte globulin (ATLG) for the prevention of declining C-peptide production in patients with recent-onset T1D. Patients have already been treated in GIRO, and clinical data are being generated. The expected 12-month efficacy and safety interim analysis will provide an important near-term milestone and inform the pivotal study program. This next stage marks an important expansion beyond transplantation and reflects Neovii’s strategy to apply its expertise in immune modulation to autoimmune and immune-mediated diseases with strong biological rationale
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