Sylentis, PharmaMar Group, initiates a Phase I clinical trial with SYL1801 for retinal diseases

This Phase I trial will enroll 36 healthy volunteers and will be conducted at the Hospital Universitario Ramón y Cajal in Madrid (Spain). The safety of SYL1801 at different doses, as well as its pharmacokinetic profile, will be evaluated. SYL1801 has been developed by Sylentis and is based on RNA interference (RNAi) technology. The compound will be administered as eye drops for the treatment and/or prevention of retinal diseases, such as agerelated macular degeneration or diabetic retinopathy Sylentis, a wholly owned subsidiary of PharmaMar Group (MSE:PHM), has announced today the initiation of the first Phase I trial with its investigational compound SYL1801 for the treatment and/or prevention of choroidal neovascularization, a common cause of retinal diseases such as Agerelated Macular Degeneration (AMD) and diabetic retinopathy. This is a Phase I clinical trial involving 36 healthy volunteers and will be carried out at the Ramón y Cajal University Hospital in Madrid (Spain). This study will evaluate the safety of SYL1801 at different doses, along with the pharmacokinetic profile of the product. SYL1801 is a compound based on RNA interference (RNAi), administered in the form of eye drops, which blocks the synthesis of the receptor NRARP (NOTCH Regulated Ankyrin Repeat Protein), involved in choroidal neovascularization (AMD pathology). Currently, neovascular AMD is mostly treated with regular intravitreal injections of anti-VEGF agents, a very uncomfortable procedure for patients and also a huge investment of financial and time resources for healthcare systems. SYL1801 represents a breakthrough in innovative drug development through RNAi-based gene silencing technology and, administered in the form of eye drops, could change the treatment paradigm for this disease. It is estimated that the number of individuals with AMD will reach 288 million, worldwide, by 2040. AMD is the leading cause of irreversible visual impairment in the elderly population of developed countries, accounting for 8% of all cases of blindness around the world. In fact, the overall prevalence of AMD between 45 and 85 years of age is 8.7%. Ana Isabel Jiménez, COO and head of R&D at Sylentis, comments that “The compounds traditionally used to treat retinal diseases are antibodies, large molecules that cannot reach the retina from the ocular surface. This is why they are administered through intravitreal injections. Patients with age-related macular degeneration or diabetic retinopathy must periodically visit the hospital, where this type of procedure, which is often associated with a negative emotional impact and a large expenditure of time, is performed.” Sylentis is a leading research company in gene silencing technology using RNAi and is one of the few to apply this technology in the field of ophthalmology. Explanatory video: What is RNA interference?

The release as fetched from its publisher. pharmamar.com ↗