Neovii Advances FDA Fast Track-Designated ATLG Program In Type 1 Diabetes With Pivotal Phase 2 Study // Company Appoints Physician-Scientist Salvatore Alesci As Chief Medical Officer
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Neovii Advances FDA Fast Track-Designated ATLG Program in Type 1 Diabetes with Pivotal Phase 2 study // Company appoints physician-scientist Salvatore Alesci as Chief Medical Officer 22.10.2026 / 11:30 CET/CEST PRESS RELEASE 21.10.2026 Neovii Advances FDA Fast Track-Designated ATLG Program in Type 1 Diabetes with Company-Sponsored Pivotal Phase 2 Study in the United States and European Union Company appoints physician-scientist Salvatore“Salvo” Alesci, M.D., Ph.D., as Chief Medical Officer to lead clinical development as Neovii expands into immune-mediated diseases. Boston, Massachusetts, USA, and Rapperswil-Jona, Switzerland, 20.10.2026 – Neovii Pharmaceuticals AG, a Swiss-headquartered, commercial-stage biopharmaceutical company with more than four decades of experience in antibody-based immunotherapies, today announced 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 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. 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. Scientific Rationale for ATLG in Type 1 Diabetes 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. Executive Commentary 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. As we take this important step in expanding Neovii's clinical development activities, I am also delighted to welcome Salvo to Neovii as our Chief Medical Officer. His expertise in endocrinology, translational medicine, and clinical development will be highly valuable as we advance our Type 1 Diabetes program and evaluate future opportunities in immune-mediated diseases.” 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.” About Salvatore Alesci, M.D., Ph.D. Dr. Alesci is a physician-scientist and biopharmaceutical executive 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. Throughout his career, he has held senior leadership roles in biotechnology and pharmaceutical organizations, leading multidisciplinary global programs from early research through late-stage clinical development. About Neovii Pharmaceuticals AG Neovii Pharmaceuticals AG is a Swiss-headquartered, fully integrated biopharmaceutical company focused on developing, manufacturing, and commercializing antibody-based therapy for immune-mediated diseases. The company markets Grafalon® (ATLG, formerly named as 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. Building on decades of expertise in immune modulation, Neovii is expanding its research and development activities into selected autoimmune and immune-mediated diseases with significant unmet medical need. ATLG is investigational in Type 1 Diabetes and has not been approved for this use. Nothing in this release should be interpreted as promoting ATLG for an unapproved indication. Forward-Looking Statement This press release contains forward-looking statements regarding Neovii's planned clinical development activities, regulatory interactions, clinical-study design and execution, business strategy, and potential future registration pathways. These statements are based on current beliefs, expectations, and assumptions and involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Clinical development outcomes, regulatory decisions, trial initiation and enrollment, safety and efficacy findings, development timelines, manufacturing readiness, and business objectives are subject to factors beyond Neovii's control. 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. Neovii undertakes no obligation to update these forward-looking statements except as required by applicable law. Reference: Saudek, F., et al. The Review of Diabetic Studies, Vol. 1, No. 2, 2004. Media contact Neovii Pharmaceuticals AG, ..., End of Media Release |
2420328 22.10.2026 CET/CEST
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