Clinical Trials

Date: 2010-11-22

Type of information: Initiation of the trial

phase: 1-2

Announcement: initiation of the trial

Company: Sylentis (Spain)

Product: SYL040012

Action mechanism:

RNAi/siRNA. SYL040012 is a specific RNAi which targets the ?-2 adrenergic receptor. It has proven effective in diminishing intraocular pressure in animal models in vivo and also in preventing glaucoma, and was found to be superior to the drugs used in the control branch of the trial.

Disease: ocular hypertension., glaucoma

Therapeutic area: Ophtalmological diseases

Country: Spain

Trial details:

Latest news:

• On November 22, 2010, Sylentis has commenced a Phase I/II clinical trial with SYL040012 for treating patients with ocular hypertension.
• On September 6, 2010, Sylentis, a biopharmaceutical subsidiary of Grupo Zeltia, has received authorisation from the Spanish Medicines and Health Products Agency to commence a second Phase I/II clinical trial with SYL040012 for treating ocular hypertension. The goal of the Phase I/II trial is to establish the tolerance and effect of SYL040012 on intraocular pressure in patients with ocular hypertension. This is the second clinical trial with SYL040012.
The Phase I/II trial with SYL040012 will be performed at the Navarra University Clinic and the Ramón y Cajal University Hospital in Madrid on patients with intraocular pressure of 21 mm Hg or greater.
After assessing the very favourable results obtained in Phase I, which established the safety of SYL040012 in healthy volunteers, Sylentis is continuing with development of the compound. The participants in the new trial, who have ocular hypertension (> 21 mm Hg), will be carefully monitored to ensure their safety.