The Phase I study is an open-label, single center, ascending dose trial that will determine the safety and tolerance of multiple administrations of the synthetic retinoid drug in approximately 18 healthy adult volunteers. Participants will be enrolled in up to six cohorts of increasing doses.
The drug is being developed for the potential treatment of Leber’s congenital amourosis (LCA), an inherited progressive retinal degenerative disease that leads to retinal dysfunction and visual impairment beginning at birth.
Bob Butchofsky, president and CEO of QLT, said: “We believe our retinoid synthetic drug program is a very interesting opportunity as there are no currently available treatments for patients with LCA, which affects one in 100,000 newborns world-wide.
“This program also supports the company’s new ocular focus and we look forward to reporting the Phase I data in the first half of 2009. We hope that our findings will support further clinical studies in this orphan indication.”