Neovii Pharmaceuticals AG, a Swiss-headquartered, commercial-stage biopharmaceutical company with over four decades of experience in antibody-based immunotherapies, has announced 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 move marks a significant strategic expansion beyond transplantation into autoimmune diseases and underscores the company’s intent to pursue immune modulation therapies for conditions with substantial unmet medical need.
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 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.
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, providing a clinical and mechanistic rationale for the current development program.
ATLG has been used in transplantation medicine for more than four decades. Neovii is now evaluating its potential role in autoimmune disease, 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.
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. He will oversee the Type 1 Diabetes program and help shape the company’s broader clinical development strategy. Frederic Prince, Ph.D., Chief Executive Officer of Neovii, commented that ATLG’s well-characterized activity against activated T cells, clinical proof of concept, and extensive clinical experience provide a strong foundation for further evaluation, and welcomed Dr. Alesci’s expertise in endocrinology and translational medicine.
The announcement, detailed in the full release, signals Neovii’s ambition to become a key player in immune-mediated diseases. With ATLG investigational in T1D and not yet approved for this use, the pivotal Phase 2 study will be closely watched by investors, clinicians, and patients. The company’s strategy leverages its manufacturing and clinical experience, as noted on Neovii’s website, to address significant unmet need. For the T1D community, the study offers hope for a disease-modifying therapy that could preserve beta-cell function and reduce treatment burden. For Neovii, it represents a high-stakes test of its expansion strategy, with regulatory and clinical milestones ahead.
