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news.Quark Pharmaceuticals has dosed the first patient with recent onset of non-arteritic anterior ischemic optic neuropathy (NAION) in its ongoing Phase I study of QPI-1007, the company's proprietary synthetic siRNA drug candidate for ocular neuroprotection.
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The Phase I study was commenced during the first quarter of 2010 to evaluate the safety, tolerability and pharmacokinetic profile of QPI-1007 in patients with chronic nerve atrophy (Stratum I) and recent onset NAION (Stratum II).
Enrollment has been completed, with no dose-limiting toxicities observed, in five of the six cohorts of Stratum I.
Quark Pharma said that it will recruit up to 30 NAION patients in Stratum II.
In addition to safety and pharmacokinetic assessments, changes in visual acuity and visual field following the administration of QPI-1007 will be measured.
Quark CEO Daniel Zurr said that after escalating to the highest planned dose of QPI-1007 in patients with chronic nerve atrophy, they are excited to dose the first NAION patient in the ongoing clinical study of QPI-1007, which has demonstrated significant neuroprotective activity in preclinical studies.