Neovii Pharmaceuticals AG, a Swiss-headquartered, commercial-stage biopharmaceutical company with more than 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 move marks a significant expansion beyond transplantation and reflects the company's strategy to apply its immune modulation expertise to autoimmune diseases with strong biological rationale and significant unmet medical need.
The 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 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. 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, 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. He is a physician-scientist with combined expertise in endocrinology and immunology and more than 25 years of experience spanning translational medicine, clinical development, regulatory strategy and scientific and patient affairs.
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.” He added that Dr. Alesci's expertise will be highly valuable as the company advances its T1D program and evaluates future opportunities in immune-mediated diseases.
Dr. Alesci 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. ATLG provides an opportunity to rigorously evaluate a differentiated immunomodulatory approach in a randomized clinical setting.”
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. The company markets Grafalon® (ATLG, formerly named ATG-F), an anti-human T-lymphocyte immunoglobulin approved in multiple countries for transplantation-related indications; approved uses vary by country. Grafalon is manufactured at Neovii's dedicated biotechnology manufacturing facility in the Munich area and is commercialized in more than 50 countries.
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 Type 1 Diabetes. For more information, visit www.neovii.com. The original release is available via NEWMEDIAWIRE.
