Clinical Trials

Date: 2017-05-30

Type of information: Initiation of the trial

phase: 3

Announcement: initiation of the trial

Company: Sylentis (Spain)

Product: SYL1001 (tivanisiran)

Action mechanism:

• RNAi/siRNA

Disease: dry eye syndrome

Therapeutic area: Ophtalmological diseases

Country: Estonia, Germany, Italy, Portugal, Slovakia, Spain

Trial details:

•  The trial, in which 300 patients are going to be enrolled, and begins with one Spanish patient, will evaluate the efficacy of the product patented by Sylentis, SYL1001, in the treatment of the signs and symptoms of dry eye disease. (NCT03108664)

Latest news:

• • On May 30, 2017, Sylentis (PharmaMar Group) has announced the start of the first Phase III study, HELIX, with the investigational new drug, SYL1001 for the indication of dry eye syndrome. The Company has agreed with the U.S. Food and Drug Administration (FDA) on plans for the Phase III clinical program, which is designed to support the submission of a New Drug Application (NDA). The Company has received final, End-of-Phase II meeting minutes from the FDA. SYL1001 is an advance in the development of innovative compounds in different therapeutic fields, through the novel technology of gene silencing, based on RNA interference (RNAi). In the HELIX study, more than 30 centers from 5 European countries, including Spain, will participate with the objective of evaluating the effect of the ophthalmological solution SYL1001 for improvements in the signs and symptoms of dry eye syndrome in about 300 patients an area in which few therapeutic options exist today. SYL1001 is a compound based on RNAi being administered in the form of eye drops that block the synthesis of a receptor implicated in the pathology of dry eye syndrome.
• In Spain it is estimated that 1 in 5 people that visit the ophthalmologist do it for this reason. Patients with dry-eye syndrome suffer the chronic loss of lubrication and hydration on the ocular surface. More than 5 million people in Spain suffer from this condition –this is between 10% and 20% of the population-1,2, mainly women over 40 years of age. The risk of developing this disorder increases in 35% every decade thereafter2. Around the world, 344 million people suffer from this syndrome.

Is general: Yes