Healthcare
Neovii Advances FDA Fast Track-Designated Type 1 Diabetes Treatment into Phase 2 Clinical Development
23 Oct 2026
Neovii Pharmaceuticals is expanding its ATLG clinical programme across the United States and European Union to investigate whether immunotherapy can help preserve insulin-producing cells in people with newly diagnosed Type 1 Diabetes. The company has also appointed physician-scientist Salvatore Alesci as Chief Medical Officer.
Swiss biopharmaceutical company Neovii Pharmaceuticals AG has announced plans to advance its anti-T-lymphocyte globulin (ATLG) programme for Type 1 Diabetes into a company-sponsored pivotal Phase 2 clinical study in the United States and European Union. The development follows the treatment's US Food and Drug Administration (FDA) Fast Track designation and builds on clinical research already underway in Europe.
Announced on 22 October 2026, the programme aims to investigate whether ATLG can preserve the body's remaining insulin-producing beta-cell function in patients with recent-onset Type 1 Diabetes. Neovii is also strengthening its clinical leadership with the appointment of Salvatore “Salvo” Alesci, M.D., Ph.D., as Chief Medical Officer, effective 15 October 2026.
The expansion represents a significant development in Neovii's strategy to move beyond transplantation medicine and explore potential treatments for autoimmune and immune-mediated diseases.
ATLG Clinical Programme Expands Across the US and Europe
The planned Phase 2 study builds on the investigator-initiated European GIRO (Grafalon in early onset) Type 1 Diabetes study, in which patients have already received treatment.
According to Neovii, an interim analysis of efficacy and safety data at 12 months is expected to provide important insights for the next stage of development. These findings will help inform the company-sponsored study and its discussions with regulatory authorities in the United States and Europe.
ATLG has received FDA Fast Track designation for the prevention of declining C-peptide production in patients with recent-onset Type 1 Diabetes. C-peptide is used as a marker of the body's own insulin production, making it relevant when evaluating whether treatments can preserve remaining beta-cell function.
Although Fast Track designation is intended to facilitate the development and review of treatments for serious conditions with unmet medical needs, it does not establish that ATLG is effective or guarantee regulatory approval.
Could Immunotherapy Help Preserve Insulin Production?
Type 1 Diabetes is a chronic autoimmune condition in which the immune system attacks and destroys insulin-producing beta cells in the pancreas. Although insulin therapy and glucose-monitoring technologies have improved disease management, preventing further loss of beta-cell function remains an important therapeutic objective.
ATLG is a polyclonal antibody-based therapy that acts on T lymphocytes, particularly activated T cells involved in immune responses. By modulating these immune pathways, researchers are investigating whether the treatment could help preserve residual insulin production following diagnosis.
Neovii says its development programme is supported by previous clinical research, including a placebo-controlled study reported by Saudek and colleagues in 2004.
The company has more than four decades of experience with ATLG in transplantation medicine, where it is marketed under the brand name Grafalon. However, ATLG remains investigational for Type 1 Diabetes and is not approved for this indication.
Frederic Prince, Ph.D., Chief Executive Officer of Neovii Pharmaceuticals, commented:
Despite major advances in glucose monitoring and insulin delivery, Type 1 Diabetes continues to impose a substantial burden on patients.
He added that the company's next clinical study will examine whether ATLG can preserve endogenous beta-cell function and reduce treatment burden.
Neovii Appoints Salvatore Alesci as Chief Medical Officer
Alongside the clinical programme expansion, Neovii has appointed Salvatore Alesci as Chief Medical Officer to lead medical and clinical development activities, including translational medicine and regulatory strategy.
Alesci brings more than 25 years of experience across endocrinology, immunology, clinical development and pharmaceutical leadership. His responsibilities will include overseeing the Type 1 Diabetes programme and evaluating future development opportunities in immune-mediated diseases.
“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,” Alesci said.
He also emphasised the importance of evaluating ATLG through rigorous clinical studies to determine its potential role in preserving insulin-producing cells.
His appointment reflects Neovii's ambition to strengthen its clinical research capabilities as it explores applications for its immunotherapy expertise beyond established transplantation indications.
What Comes Next for Neovii's Type 1 Diabetes Research?
The forthcoming 12-month interim analysis from the GIRO study represents an important milestone for Neovii's ATLG programme. Emerging safety and efficacy data are expected to inform the Phase 2 development strategy and continuing regulatory discussions.
The programme also highlights growing interest in therapies that address the autoimmune processes underlying Type 1 Diabetes rather than focusing exclusively on managing blood glucose.
However, clinical evidence will be necessary to establish whether ATLG can meaningfully preserve beta-cell function, improve patient outcomes and demonstrate an acceptable safety profile.
For Neovii, the planned Phase 2 study marks a new stage in its effort to apply established immunotherapy technologies to autoimmune diseases with substantial unmet medical needs.
About Neovii Pharmaceuticals
Neovii Pharmaceuticals AG is a Swiss-headquartered biopharmaceutical company specialising in antibody-based therapies for immune-mediated diseases.
The company develops, manufactures and commercialises Grafalon (ATLG), an immunotherapy approved for transplantation-related indications in multiple countries. Manufactured at Neovii's biotechnology facility near Munich, Grafalon is commercialised in more than 50 countries.
Neovii is expanding its research and development activities into autoimmune conditions, including Type 1 Diabetes. ATLG has not received regulatory approval for treating Type 1 Diabetes.
