Gene therapy specialist Shanghai BDgene Technology Co., Ltd has announced receiving approval from the US FDA to conduct a clinical study for its pipeline candidate, BD111, in the treatment of type I herpes simplex virus (HSV-1) stromal keratitis. HSV-1 is a pathogen responsible for a range of diseases, including oral herpes, genital herpes, keratitis, and meningitis, which are often recurrent and cannot be eradicated. Keratitis, in particular, can lead to viral keratitis, impacting corneal opacity and potentially causing corneal scar formation, neovascularization, and corneal perforation, making it a common cause of blindness in clinical practice.
BD111: A Novel Approach to HSV-1 Keratitis Treatment
BD111 utilizes BDgene’s proprietary delivery technology, VLP, to transduce CRISPR, directly targeting and cutting the genome of HSV-1 with the aim of eliminating the virus’s genome and treating herpes virus keratitis. The drug’s characteristics include: (1) the delivery of cas9 mRNA, which remains in the body for a short time, reducing the immune response and the risk of gene editing errors; (2) it edits the viral genome without altering any human genes, with no detected off-target effects on the human genome.
Orphan Drug Designation and Clinical Trial Approvals
BD111 was awarded orphan drug designation (ODD) in the US in June 2022, recognizing its potential to treat a rare disease. The drug obtained tacit clinical trial approval in China in April this year, marking a significant step forward in the global development of this innovative gene therapy.-Fineline Info & Tech
