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Vincere Bio wins grant for USP30 inhibitor IND-enabling studies in acute kidney injury

Vincere Bio wins grant for USP30 inhibitor IND-enabling studies in acute kidney injury

Vincere Biosciences, a small molecule drug developer, has received a USD 1.3 million SBIR Phase II grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to advance a USP30 inhibitor through investigational new drug (IND)-enabling studies for acute kidney injury (AKI).

AKI affects a broad patient population, with cardiac surgery-associated AKI (CSA-AKI) alone estimated to occur in up to 42% of the approximately 2 million patients undergoing cardiac surgery annually in the US. Progression to chronic kidney disease (CKD) or end-stage renal disease (ESRD) represents a significant clinical and economic burden, and standard of care remains supportive.

Vincere's approach centers on inhibiting USP30, a deubiquitinase that suppresses mitophagy — the cellular clearance mechanism for damaged mitochondria — via the PINK1/Parkin pathway. Accumulated dysfunctional mitochondria are considered a driver of AKI pathogenesis. The company reported that USP30 inhibitor (USP30i) candidates demonstrated renal functional improvement in three preclinical AKI models, including ischemia-reperfusion injury, cisplatin-induced nephrotoxicity, and rhabdomyolysis, with high USP30 potency, selectivity over other deubiquitinases, and favorable pharmacokinetic profiles in rodents.

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The Direct Phase II grant will fund three study aims: genotoxicity assessment and acute and short-term toxicology in two species; 28-day Good Laboratory Practice (GLP) toxicology in two species; and cardiovascular, respiratory, and central nervous system safety evaluation. Successful completion would support IND submission and initiation of a first-in-human study. Principal investigator Bahareh Behrouz leads the program.

Vincere reported synthesizing more than 900 small molecule USP30 inhibitors, with a subset characterized for potency, pharmacokinetics, absorption, distribution, metabolism, and excretion (ADME) properties. The firm said multiple development candidates with optimal profiles have been identified for IND-enabling progression, with the pipeline previously receiving USD 5 million from the Michael J. Fox Foundation to advance one of those candidates as a potential Parkinson's disease therapy. Mission Therapeutics, a UK-based company, has also disclosed a USP30 inhibitor program with applications in Parkinson's disease and acute organ injury. The AKI-specific small molecule space remains relatively early-stage, with no USP30 inhibitor in clinical trials for kidney indications as per available public information.


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