FDA grants IND clearance to Transcenta for IgA nephropathy treatment
The FDA granted investigational new drug clearance to Transcenta Holding Limited for TST004, its humanized monoclonal antibody that attacks the enzyme contributing to IgA nephropathy development, according to a press release.
Specifically, TST004 inhibits mannose-binding protein-associated serine protease 2 (MASP2), which plays an important role in the lectin pathway activation that leads to diseases like IgA nephropathy. TST004 was designed to keep the inflammation and tissue damage caused by the lectin pathway activation from occurring, ultimately preventing the creation of IgA nephropathy.
“There is a high unmet medical need for patients with IgA nephropathy, with around 30% to 45% of them ultimately developing end-stage kidney disease and available treatment options remaining symptomatic in nature. Targeting the lectin pathway activation with our best-in-class TST004 antibody is a potentially transformative therapeutic alternative,” Caroline Germa, MD, executive vice president of global medicine development and chief medical officer of Transcenta Holding Limited, said in the press release.
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