Neovii Pharmaceuticals AG, a Swiss-headquartered biopharmaceutical company with over four decades of experience in antibody-based immunotherapies, 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 expansion builds on the ongoing investigator-initiated European GIRO 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. The news, first reported via NEWMEDIAWIRE, signals a significant step in Neovii's strategy to apply its immune modulation expertise beyond transplantation.
Patients have already been treated in the GIRO study, and clinical data are being generated. An 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 expansion beyond transplantation and reflects Neovii's strategy to target autoimmune and immune-mediated diseases with strong biological rationale and significant unmet medical need.
In connection with this expansion, Neovii 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 broader clinical development strategy. Dr. Alesci brings more than 25 years of experience in endocrinology and immunology, with senior leadership roles in biotechnology and pharmaceutical organizations.
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 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 T1D 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.
Frederic Prince, Ph.D., Chief Executive Officer of Neovii, 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." He added that the company is advancing a pivotal Phase 2 study to assess whether ATLG can preserve endogenous beta-cell function and reduce treatment burden.
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. Fast Track designation does not guarantee that ATLG will qualify for Accelerated Approval or Priority Review, that regulatory review will be completed within any particular timeframe, or that ATLG will receive marketing approval for T1D. Neovii markets Grafalon® (ATLG) for transplantation-related indications in more than 50 countries, and the company's expansion into T1D could, if successful, offer a new immunomodulatory approach for patients with recent-onset disease. For more details, see the full release on NewMediaWire.
