Neovii Pharmaceuticals AG, a Swiss-headquartered biopharmaceutical company with over four decades of experience in antibody-based immunotherapies, announced on October 22, 2026, 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 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 the GIRO study, 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 and significant unmet medical need.
Type 1 Diabetes is a chronic autoimmune disease characterized by T-cell-mediated destruction of insulin-producing pancreatic beta cells. Many patients retain residual beta-cell function following diagnosis, and preserving this endogenous function remains an important therapeutic objective. ATLG is a polyclonal anti-T-lymphocyte globulin with preferential activity against activated T cells and broader effects across T-cell populations and immune pathways involved in autoimmune responses. Published clinical proof of concept in recent-onset Type 1 Diabetes was reported by Saudek et al. in a placebo-controlled study of ATLG. ATLG has been used in transplantation medicine for more than four decades, and Neovii is now evaluating its potential role in autoimmune disease.
In connection 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 the company’s medical and clinical development activities, including translational medicine and regulatory strategy, and will oversee the Type 1 Diabetes program. Frederic Prince, Ph.D., Chief Executive Officer of Neovii Pharmaceuticals AG, commented, “Despite major advances in glucose monitoring and insulin delivery, Type 1 Diabetes continues to impose a substantial burden on patients. ATLG’s well-characterized activity against activated T cells, clinical proof of concept in recent-onset disease, and extensive clinical experience provide a strong foundation for its further evaluation.” Dr. Alesci added, “I am excited to join Neovii at this important stage in the company’s evolution and help drive its expansion into Type 1 Diabetes and other immune-mediated diseases.”
The company is using emerging efficacy and safety data from GIRO to inform the pivotal study and support ongoing discussions with the FDA, European regulatory authorities, and other health authorities on a potential registration pathway. ATLG is investigational in Type 1 Diabetes and has not been approved for this use. For more information, see the full release or visit www.neovii.com.
