Tes Pharma Receives HREC Approval to Initiate Phase I Clinical Trial of the Lead Drug TESP-0401 for Prevention of DGF Following Kidney Transplantation
Solomeo-Corciano (PG), Italy, June 12, 2026 â Tes Pharma, a biopharmaceutical company focused on developing first-in-class therapeutics for high unmet medical needs in renal diseases, announced today that has received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the Phase I clinical trial of TESP-0401.
âWe are thrilled to receive the approval to proceed with the Phase I clinical study with our lead compound, in Australia,â said Luca Benatti, Tes Pharma CEO. âReceiving HREC approval is a landmark achievement for Tes Pharmaâ.
Andrea Pellacani, M.D., Ph.D., Tes Pharma Chief Medical Officer said: âTESP-0401 is a first-in-class inhibitor of the ACMSD enzyme in development for the prevention of delayed graft function following kidney transplantation. Targeting the de novo NADâș biosynthesis through ACMSD inhibition is an innovative, unique approach to treat renal diseases, and provides the opportunity to position TESPâ0401 as a highly differentiated drug candidate in addressing several high unmet medical needs in nephrology.â
About TESP-0401
TESPâ0401 is a firstâinâclass ACMSD inhibitor that restores NADâș levels by enhancing its de novo biosynthesis. Dysregulation of this pathway, and the resulting decline in NADâș levels, are key drivers of mitochondrial dysfunction and cellular energy failure across multiple indications, including acute (AKI) and chronic kidney diseases (CKD), as well as metabolic disorders.
By inhibiting ACMSD, selectively and highly expressed in tubular epithelial cells, TESPâ0401 restores NADâș levels in the kidney, thereby supporting mitochondrial function and cellular energetics. This mechanism targets a fundamental driver of disease progression, enabling recovery of essential cellular processes and improving cellular homeostasis under conditions of stress and injury.
Importantly, TESPâ0401 not only confers protection in AKI but also extends its therapeutic potential to CKD, where mitochondrial dysfunction and tubular injury contribute to progressive loss of renal function and fibrosis. By targeting NADâș metabolism, TESPâ0401 represents a novel and differentiated approach to prevent tubular damage, reduce fibrosis, and preserve kidney function in renal diseases.
About Tes Pharma
Tes Pharma, a biopharmaceutical company focused on developing first-in-class therapeutics for high unmet medical needs in renal diseases. The companyâs lead compound TESP-0401 demonstrated significant effect in models of acute (AKI) and chronic kidney diseases (CKD). TESP-0401 is entering first-in human studies in 2026 for prevention of delayed graft function in kidney transplantation. Tes Pharma pipeline includes a series of compounds for CKD and renal fibrosis in different stages of preclinical development.
For more information, please visit www.tespharma.com or connect with the Company on LinkedIn
For further information, please contact:
Sara Malincarne
smalincarne@tespharma.com