Neovii Pharmaceuticals AG is advancing its Type 1 Diabetes clinical program through a company-sponsored pivotal Phase 2 study in the United States and European Union, the Swiss-headquartered biopharmaceutical company announced. The expansion builds on the ongoing investigator-initiated European GIRO study and is supported by U.S. Food and Drug Administration Fast Track designation for anti-T-lymphocyte globulin, or ATLG, for the prevention of declining C-peptide production in patients with recent-onset Type 1 Diabetes.
The announcement matters because it signals a commercial-stage transplantation specialist moving into autoimmune disease, where Type 1 Diabetes remains a condition managed rather than modified. Patients have already been treated in GIRO, and clinical data are being generated. An expected 12-month efficacy and safety interim analysis will serve as a near-term milestone and inform the pivotal study program, according to the release issued through NEWMEDIAWIRE.
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 after diagnosis, and preserving that endogenous function is an important therapeutic objective. ATLG is a polyclonal anti-T-lymphocyte globulin with preferential activity against activated T cells and broader effects across immune pathways involved in autoimmune responses. Published clinical proof of concept in recent-onset disease was reported by Saudek et al. in a placebo-controlled study, and ATLG has been used in transplantation medicine for more than four decades.
Neovii is using emerging efficacy and safety data from GIRO to inform the pivotal study and support discussions with the FDA, European regulators and other health authorities on a potential registration pathway. The company markets Grafalon, an anti-human T-lymphocyte immunoglobulin approved in multiple countries for transplantation-related indications, and manufactures it at a dedicated facility in the Munich area. ATLG remains investigational in Type 1 Diabetes and has not been approved for that use.
Frederic Prince, Ph.D., chief executive officer of Neovii, said that despite advances in glucose monitoring and insulin delivery, Type 1 Diabetes continues to impose a substantial burden on patients, and that ATLG’s activity against activated T cells, clinical proof of concept and extensive clinical experience provide a strong foundation for further evaluation.
In connection with the expansion, Neovii appointed Salvatore “Salvo” Alesci, M.D., Ph.D., as chief medical officer effective October 15, 2026. A physician-scientist with combined expertise in endocrinology and immunology and more than 25 years of experience, Alesci will lead medical and clinical development activities, including translational medicine and regulatory strategy, and will oversee the Type 1 Diabetes program. He said preservation of endogenous beta-cell function remains an important therapeutic objective and that ATLG offers an opportunity to rigorously evaluate a differentiated immunomodulatory approach in a randomized setting.
The company cautioned that Fast Track designation does not guarantee Accelerated Approval, Priority Review or marketing approval for Type 1 Diabetes, and that clinical timelines and outcomes remain subject to significant risks and uncertainties. Additional details are available in the original release.
