NIAON- non-arteritic anterior ischemic optic neuropathy is the leading cause of sudden vision loss in people over 50, This condition can steal the joy from someone’s retirement years.
Nonarteritic anterior ischemic optic neuropathy is an isolated white-matter stroke of the optic nerve (ON). NAION is the most common cause of sudden optic nerve-related vision loss, affecting more than 10,000 Americans every year, often bilaterally. It was reported that there were no clinically effective treatments existed, because only a little is known about its pathophysiology, and there are few histopathological studies of the acute condition.
Now, Quark Pharmaceuticals, Inc has come out with the ocular neuro protectant QPI-1007 for which United States Patent and Trademark Office (“USPTO”) has granted a key patent covering the treatment of patients suffering from non-arteritic anterior ischemic optic neuropathy (“NAION”).
Quark Pharmaceuticals, Inc. is a late clinical-stage pharmaceutical company, a leader in the discovery and development of novel RNAi-based therapeutics for unmet medical needs. Two products, which were granted Orphan designation, QPI -1002 and QP -1007 are in global phase III pivotal clinical studies for Delayed Graft Function (DGF) and Non Arteritic Ischemic Optic Neuropathy (NAION) respectively.
QPI-1007 received Orphan Drug status from the FDA for this indication and it is currently being evaluated in a global Phase II/III study, QRK207, to determine the effect of QPI-1007 on visual function in subjects with acute NAION.
QPI-1007 is a double-stranded chemically-modified, synthetic small interfering RNA (siRNA) targeting the mRNA of the caspase 2 gene and is designed to temporarily inhibit the expression of caspase 2 via the RNA interference (RNAi) pathway. The chemically modified structure of QPI-1007 was developed internally by Quark and is covered by Quark’s patent applications. The compound is designed to allow high, specific RNAi activity while attenuating off-target and immunostimulatory effects. QPI 1007 is being developed as a neuroprotectant for the treatment of non-arteritic ischemic optic neuropathy (NAION) and other optic neuropathies such as glaucoma that result in the death of retinal ganglion cells (RGCs). QPI-1007 has been granted orphan designation by the FDA for the indication of NAION.
The QRK207 study is already enrolling in several countries, including the US and India with additional sites in Israel, Germany, Australia, Italy, and China opening soon. The clinical study is run by Quark in collaboration with Quark’s partners Biocon Ltd in India and the Chinese joint venture company of Quark in China, Kunshan RiboQuark Pharmaceutical Technology Co., Ltd.
Dr. Daniel Zurr, CEO of Quark said “NAION is a serious condition, typically causing sudden vision loss without pain, the lack of treatment for this condition is a globally unmet medical need,”Our drug, QPI-1007, has been shown in preclinical studies to be a neuroprotectant with a novel mechanism of action to block apoptotic cell death. We plan to expand the QPI-1007 program to additional ocular neuropathies that share the hallmark trait of retinal ganglion cell death, such as glaucoma.
This novel patent will expire in 2033 with potential for term extension.
Keywords: QPI-1007, NAION, Quark Pharmaceuticals, Inc., U.S.A. Patent, USPTO.