Quark Pharmaceuticals has started dosing the first patient in a Phase IIa trial of its neuroprotective agent QPI-1007 when administered by single intravitreal (IVT) injection in patients suffering an acute attack of primary angle closure glaucoma (PACG).
The double-masked, randomised sham controlled trial is designed to assess the safety, tolerability and pharmacokinetics of QPI-1007 in these patients.
QPI-1007 is a siRNA designed to temporarily inhibit the expression of Caspase 2, a protein that has been shown to play a role in retinal ganglion cell (RGC) cell death.
At present, QPI-1007 is being investigated for treatment of non-arteritic ischemic optic neuropathy (NAION).
Quark recently completed a Phase I/IIa multicentre clinical trial in the US and Israel, which showed that a single intravitreal injection of QPI-1007 resulted in a neuroprotective effect in NAION patients.
Around 60 patients with unilateral acute PACG (APACG) will be enrolled in the Phase IIa trial of QPI-1007, which is carried out in several centres in the US, Vietnam and Singapore.
Patients participating in the trial will be randomised at a 1:1 ratio to receive 1.5mg IVT injection of QPI-1007 (active group) or sham injection (control group).
The primary objective of the trial is to evaluate the safety, tolerability and pharmacokinetics of QPI-1007 in subjects with acute primary angle-closure glaucoma.
In addition, the biological activity of the drug will also be studied by comparing the active group and control group study eyes at month four with respect to a series of visual function parameters.