Quark doses first patient in Phase IIa trial of glaucoma drug candidate QPI-1007

The double-masked, randomized sham controlled trial is designed to evaluate the safety, tolerability and pharmacokinetics of QPI-1007 in these patients.

QPI-1007 is a siRNA designed drug designed to temporarily inhibit the expression of Caspase 2 developed by the company based on entirely its internally developed intellectual property.

Caspase 2 is a protein that has been shown to play a role in retinal ganglion cell (RGC) cell death.

Currently, QPI-1007 is under investigation for the treatment of non-arteritic ischemic optic neuropathy (NAION).

The company recently announced the completion of a Phase I/IIa multicenter 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.

About 60 patients with unilateral acute PACG (APACG) are expected to be enrolled in the Phase IIa trial of QPI-1007, which is carried out in several centers in the US, Vietnam, and Singapore.

In the trial patients will be randomized at a 1:1 ratio to receive 1.5mg IVT injection of QPI-1007 (active group) or sham injection (control group).

The trial’s primary objective is to assess the safety, tolerability and pharmacokinetics of QPI-1007 in subjects with acute primary angle-closure glaucoma.

Additionally, the biological activity of the drug will also be studied by comparing the active group and control group study eyes at month 4 with respect to a series of visual function parameters.

Image: Quark Phase IIa trial of QPI-1007 will enrol about 60 patients with unilateral acute PACG (APACG). Photo: courtesy of cuteimage/ freedigitalphotos.net