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 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 and significant unmet medical need. 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, including the evaluation of future development opportunities.
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. Together with other clinical evidence that modulation of pathogenic T-cell responses can preserve residual beta-cell function, these findings provide a clinical and mechanistic rationale for evaluating ATLG in the ongoing GIRO T1D study and company-sponsored pivotal Phase 2 study.
ATLG has been used in transplantation medicine for more than four decades. Building on this extensive manufacturing, preclinical, and clinical experience, Neovii is now evaluating its potential role in autoimmune disease. The investigator-initiated European GIRO T1D study and the company-sponsored pivotal Phase 2 study in the United States and the European Union are complementary components of the ATLG clinical development program. Neovii 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.
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. Building on the investigator-initiated GIRO T1D study, we are advancing a company-sponsored pivotal Phase 2 study to assess whether ATLG can preserve endogenous beta-cell function and reduce treatment burden.”
Salvatore Alesci, M.D., Ph.D., Chief Medical Officer of Neovii Pharmaceuticals AG, said: “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. Despite significant advances in disease management, preservation of endogenous beta-cell function remains an important therapeutic objective in Type 1 Diabetes. ATLG provides an opportunity to rigorously evaluate a differentiated immunomodulatory approach in a randomized clinical setting. I look forward to working with the Neovii team, investigators, patients, advocacy groups, and regulatory authorities to execute a scientifically rigorous Type 1 Diabetes development program and shape the company’s broader clinical strategy in immune-mediated diseases.”
For more information, visit www.neovii.com or view the original release on www.newmediawire.com.
