Shanghai BDgene Technology Co., Ltd has announced that it has received tacit clinical trial approval from the Center for Drug Evaluation (CDE) for its innovative therapy, BD111. This CRISPR-Cas9 in vivo-based therapy is designed for the treatment of recurrent type 1 herpes simplex virus (HSV-1)-related keratitis (HSK) and is being assessed as a second-line treatment option.
Understanding HSV-1 and Its Impact on Eye Health
HSV-1 is a significant pathogen responsible for a range of diseases including oral herpes, genital herpes, keratitis, and meningitis. Characterized by latent infections, these diseases often recur and are difficult to eradicate. HSV-1 infected keratitis can lead to viral keratitis, potentially causing corneal opacity, scar formation, neovascularization, and even corneal perforation. It is a common cause of blindness in clinical practice.
BD111: A Pioneering Gene-Editing Approach
BD111 has been developed utilizing BDgene’s proprietary BDmRNA delivery technology, which is the only globally recognized technology for Cas9 mRNA delivery via lentivirus. The mechanism of action involves the application of CRISPR gene-editing tools to directly target and edit the HSV-1 genome, with the aim of removing the virus to treat HSK. This cutting-edge approach to gene editing has the potential to revolutionize treatment for HSV-1-related conditions.
Orphan Drug Designation and Future Prospects
BD111 has obtained orphan drug designation (ODD) status from the US FDA in June of the previous year, highlighting its potential as a treatment for rare diseases. This designation underscores the importance of BD111 in addressing unmet medical needs and its potential to offer new hope to patients suffering from HSV-1-related keratitis.-Fineline Info & Tech
