Quark Pharmaceuticals said this week that it has dosed the first patient with recent onset of non-arteritic anterior ischemic optic neuropathy in an ongoing Phase I study of QPI-1007, its synthetic siRNA drug candidate for ocular neuroprotection.
The Phase I open-label, dose-escalation study is being conducted in the US and Israel with two patient subgroups — stratum I, which includes patients with chronic nerve atrophy and began dosing in March (GSN 3/4/2010); and stratum II, which is enrolling patients with recent onset of NAION.
The company said this week that enrollment has been completed in five of the six cohorts of stratum I and that dosing at the highest planned dose level has been initiated in this patient population "with no dose-limiting toxicities observed."
Quark plans to enroll up to 30 NAION patients in stratum II. In addition to safety and pharmacokinetic assessments, the company will measure changes in visual acuity and visual field following the administration of QPI-1007.
The Phase I study is expected to enroll up to 66 patients in total who will receive a single intravitreal injection of QPI-1007 at varying doses with assessments of safety and tolerability for 12 months post-injection.
The company disclosed earlier this month in a filing with the US Securities and Exchange Commission that it expects preliminary results from the first patient subgroup to be available in the first quarter of next year and that dosing for NAION patients will be completed in the first half of 2011 (GSN 10/7/2010).
Quark said in the filing that it plans to ultimately develop QPI-1007 as a treatment for glaucoma and that it is still determining whether to launch a phase II trial in acute glaucoma patients and/or in NAION patients.