FREMONT, Calif., October 14, 2016 — Quark Pharmaceuticals, Inc. today announced the launch of www.EyeActNow.com to promote public awareness and subject recruitment for a global Phase II/III clinical study evaluating QPI-1007, an investigational drug designed to stop further vision loss in patients with early diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy, or NAION.
Often referred to as ‘Stroke of the Eye,’ NAION is characterized by sudden vision loss in one eye without pain.
“The availability of treatment for this condition is a globally unmet medical need,” Quark CEO Danny Zurr said.
The study, known as QRK207, seeks to evaluate the safety and efficacy of QPI-1007, a novel siRNA (small interfering RNA) drug candidate for ocular neuroprotection.
The study is currently open for enrollment and is being conducted at multiple sites in the United States, India, Israel, Germany, Australia, and Italy with China opening soon, and will be limited to approximately 530 subjects globally. Each subject will be evaluated for vision and health for 12 months.
To be evaluated for study eligibility, patients must have experienced sudden vision loss in the last 14 days. To underscore how crucial it is to seek early diagnosis, EyeActNow.com prominently features a video of leading ophthalmologists explaining NAION symptoms and urging patients to immediately see an eye care professional in the event of sudden vision loss.
“Any patient who loses part or all of his or her vision should see an ophthalmologist or optometrist as soon as possible,” Dr. Neil R. Miller, Frank B. Walsh Professor of Neuro-ophthalmology and Professor of Ophthalmology at Johns Hopkins Medicine, says.
Adds Dr. Mark Kupersmith, Professor of Neurology and of Ophthalmology and Neurosurgery at New York Eye & Ear Infirmary of Mount Sinai: “If you wake up with acute vision loss, not just a little blur, not just a little fuzzy vision, but you have areas of patches that you can’t see through, which we call scotomas, you really need emergent care. And that means you’ll have to go to your eye care specialist to look for retinal detachment, or hemorrhages in the eye, or strokes in the retina, or strokes in the optic nerve like NAION.”
In addition to having experienced sudden vision loss in the last 14 days, eligibility criteria for the study include:
- Ages 50 to 80 years old
- No treatment for current set of vision loss symptoms
- Other criteria to be evaluated at a study-participating clinical site
Quark is conducting the study in collaboration with the Neuro-Ophthalmology Research Disease Investigator Consortium, or NORDIC.
QPI-1007 is a double stranded RNA molecule chemically modified by Quark’s proprietary technology. The drug is designed to temporarily inhibit the expression of caspase 2 and thereby block the apoptotic death of retinal ganglion cells. QPI-1007 is being developed as a neuroprotectant for the treatment of NAION and in the future other optic neuropathies such as glaucoma that result in the death of retinal ganglion cells (RGCs). QPI-1007 has been evaluated in a human, dose escalation, Phase I/IIa Study (Protocol QRK007), delivered by single intravitreal injection to Optic Nerve Atrophy patients with low visual acuity and thereafter in acute NAION patients. This study was conducted at 22 sites in the US and 6 sites in Israel. This study showed that a single intravitreal injection of QPI-1007 was well tolerated in subjects with long-standing low vision or acute NAION. The drug has also demonstrated protective activity compared to historical data. QPI-1007 was also studied in a Phase IIa clinical trial in acute angle closure glaucoma patients in the United States, Vietnam and Singapore.
About Quark Pharmaceuticals, Inc.
Quark Pharmaceuticals, Inc. is a late clinical-stage pharmaceutical company, discovering and developing novel RNAi-based therapeutics for unmet medical needs. Two products, QPI -1002 for Delayed Graft Function (DGF) and QP -1007 for Non Arteritic Ischemic Optic Neuropathy (NAION) are in global phase III pivotal clinical studies, each of which was granted Orphan designation. The Company is also conducting several Phase II clinical trials. Quark’s broad pipeline of clinical and preclinical product candidates is generated by the company’s internally developed technology, which includes Quark’s RNAi platform technology and its delivery to a host of organs. Quark is headquartered in Fremont, California and operates research facilities in Ness-Ziona, Israel. For additional information please visit: www.quarkpharma.com.