Sirna Reports Interim Results From Trial With Sirna-027 in AMD

Sirna Therapeutics has reported interim data from the ongoing Phase I trial for Sirna-027, an siRNA therapeutic for treatment of age-related macular degeneration (AMD).

Sirna-027 appears to be safe and well-tolerated at doses tested to date, with no systemic or local adverse events related to the drug. No dose-limiting toxicity has been observed; thus the maximum-tolerated dose has not been established. The data demonstrated that visual acuity stabilized in all patients tested.

The open-label, dose-escalation study is ongoing in four prestigious clinical centers: the Wilmer Eye Institute, The Johns Hopkins University; The Cole Eye Institute at The Cleveland Clinic; the Joint Clinical Research Center, Harvard University, Massachusetts Eye and Ear Infirmary; and the Jules Stein Eye Institute, University of California Los Angeles.

The purposes of the trial are to establish the safety and tolerability of Sirna-027, its clinical effect on visual acuity, and its potential for biological effect by monitoring changes in optical coherence tomography and fluorescein angiography. To date, 14 patients have each received a single intravitreal dose of Sirna-027 ranging from 100 to 800 mcg. So far, all patients have experienced visual acuity stabilization during their trial participation, with the longest assessment being 84 days.