Neovii Advances FDA Fast Track ATLG T1D Program, Appoints CMO

Neovii Pharmaceuticals AG, a Swiss-headquartered commercial-stage biopharmaceutical company with over four decades of experience in antibody-based immunotherapies, is advancing its Type 1 Diabetes (T1D) clinical program with a company-sponsored pivotal Phase 2 study in the United States and European Union. This 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 an expected 12-month efficacy and safety interim analysis will provide a near-term milestone to inform the pivotal program. This marks Neovii’s strategic expansion beyond transplantation into autoimmune and immune-mediated diseases with significant unmet need.

In conjunction with this expansion, Neovii has appointed Salvatore “Salvo” Alesci, M.D., Ph.D., as Chief Medical Officer, effective October 15, 2026. Dr. Alesci will lead medical and clinical development activities, including translational medicine and regulatory strategy, and will oversee the T1D program. ATLG is a polyclonal anti-T-lymphocyte globulin with preferential activity against activated T cells, and published clinical proof of concept in recent-onset T1D supports its evaluation. ATLG has been used in transplantation medicine for more than four decades, and Neovii is now evaluating its potential in autoimmune disease. The GIRO study and the pivotal Phase 2 study are complementary components of the ATLG clinical development program, with emerging data informing regulatory discussions.

Frederic Prince, Ph.D., Chief Executive Officer of Neovii, commented that despite advances in glucose monitoring and insulin delivery, T1D continues to impose a substantial burden on patients, and ATLG’s well-characterized activity, clinical proof of concept, and extensive clinical experience provide a strong foundation for further evaluation. Dr. Alesci expressed excitement about joining Neovii at this important stage and highlighted that preservation of endogenous beta-cell function remains an important therapeutic objective. Neovii markets Grafalon® (ATLG) for transplantation-related indications in more than 50 countries. ATLG is investigational in T1D and has not been approved for this use. For more information, visit www.neovii.com.