Kunshan RiboQuark Pharmaceutical Technology has started patient enrolment in a Phase II/III clinical trial (QRK207) of ocular neuroprotectant QPI-1007 to treat non-arteritic ischemic optic neuropathy (NAION) in China.
QPI-1007 is a synthetic small interfering RNA (siRNA) being developed to temporarily inhibit expression of the Caspase 2 pro-apoptotic protein.
The randomised, double-masked, sham-controlled Phase II/III trial is designed to evaluate the effect of QPI-1007 multi-dose intravitreal injections on visual function in a total of 465 patients with acute NAION.
QRK207 will compare the safety and efficacy of two doses of QPI-1007 over 12 months at about 90 hospitals across several countries such as China, US, Israel, Germany, Australia, Italy and India.
RiboQuark chairman Liang Zicai said: “RiboQuark is committed to developing innovative therapies that address unmet medical needs, and the initiation of the Phase II/III study investigating QPI-1007 in NAION in China is an important step towards this goal.
“China has a significant NAION patient population, and we are pleased to be the first in the country to provide a siRNA-based therapy that is likely to benefit many patients in need, and to have the first patient ever dosed on a siRNA trial in China.”
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below formBy GlobalData
RiboQuark is established as a Chinese-foreign equity joint venture between Suzhou Ribo Life Science and Quark Pharmaceuticals.
Quark obtained the China Food and Drug Administration (CFDA) for conducting the QRK207 trial in partnership with Neuro-Ophthalmology Research Disease Investigator Consortium.
QPI-1007 is reported to have demonstrated safe neuroprotective activity in NAION patients in a previous open label, single-dose, dose escalation Phase I trial at 16 US centres and five Israeli sites.