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.”
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.