Neovii Pharmaceuticals AG, a Swiss commercial-stage biopharmaceutical company, 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 announcement, reported via NEWMEDIAWIRE, signals a significant step in the company’s strategy to expand beyond transplantation into autoimmune diseases with substantial unmet need. The study 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.
The FDA Fast Track designation is intended to expedite the development and review of therapies that address serious conditions and fill an unmet medical need. For Neovii, it provides a regulatory pathway that could accelerate the availability of a novel immunomodulatory approach for T1D, 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 this endogenous function remains a key therapeutic objective. ATLG, a polyclonal anti-T-lymphocyte globulin with preferential activity against activated T cells, has shown clinical proof of concept in recent-onset T1D, as reported by Saudek et al. in a placebo-controlled study.
Patients have already been treated in the GIRO study, and a 12-month efficacy and safety interim analysis is expected to provide an important near-term milestone. Neovii is using emerging data from GIRO to inform the pivotal study and support discussions with the FDA, European regulatory authorities, and other health authorities on a potential registration pathway. The company has more than four decades of experience in antibody-based immunotherapies, and ATLG has been used in transplantation medicine for over four decades. This extensive manufacturing, preclinical, and clinical experience provides a strong foundation for evaluating ATLG in autoimmune disease.
In connection with the expansion, Neovii has appointed Salvatore “Salvo” Alesci, M.D., Ph.D., as Chief Medical Officer, effective October 15, 2026. Dr. Alesci, a physician-scientist with combined expertise in endocrinology and immunology and more than 25 years of experience, 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 broader clinical development strategy. Frederic Prince, Ph.D., Chief Executive Officer of Neovii, said, “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.” Dr. Alesci added, “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.”
The pivotal Phase 2 study represents a critical test of whether ATLG can preserve endogenous beta-cell function and reduce treatment burden for patients. If successful, it could offer a differentiated immunomodulatory approach in a disease where current management relies heavily on glucose monitoring and insulin delivery. However, Neovii cautions that Fast Track designation does not guarantee Accelerated Approval or Priority Review, and ATLG remains investigational in T1D. For a company with a commercial-stage transplant franchise, this program marks a strategic pivot toward autoimmune indications with strong biological rationale. Further details are available in the original release.
