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US FDA Grants Fast Track Status to Nacuity’s Oral RP Candidate
Author: Jennie Crabbe
Nacuity Pharmaceuticals announced Jan. 21 that the US FDA had granted fast track designation to NPI-001 (N-acetylcysteine amide) tablets, Nacuity’s oral retinitis pigmentosa (RP) treatment candidate.
Nacuity, of Fort Worth, Texas, said NPI-001 is a potent antioxidant being developed to target oxidative stress associated with diseases such as RP.
Preclinical studies indicate that NPI-001 boosts glutathione, the body’s most powerful endogenous antioxidant, to stop chemically aggressive oxygen molecules from damaging retinal cells.
NPI-001 has also been granted the orphan drug designation.
RP can involve more than 3 thousand mutations in more than 50 genes. Nacuity said its approach is gene-agnostic.
Nacuity is also advancing NPI-002, an antioxidant intravitreal implant for delaying cataract progression in vitrectomy patients.
