Aerie Pharmaceuticals initiates phase IIb study of PG324
Aerie Pharmaceuticals, a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, has dosed the first patients enrolled in the company's phase IIb study of PG324, a novel, fixed-combination of Aerie's AR-13324 and latanoprost, a prostaglandin analogue that is the most widely prescribed glaucoma drug. The 28-day, phase IIb clinical trial is expected to enroll approximately 300 patients with glaucoma or ocular hypertension and will compare two concentrations of PG324 to latanoprost and to AR-13324, all dosed once daily. The efficacy endpoint will be superiority of PG324 to each of its components, as measured by the lowering of mean diurnal intraocular pressure (IOP) on day 28 compared to baseline. Topline results of this trial currently are expected in mid-2014.
Brian Levy, O.D., M.Sc., Aerie's chief medical officer, said, "Aerie's phase IIb trial of PG324 is based on substantial and compelling results we have achieved with our lead candidate, AR-13324, as well as preclinical proof of concept studies for PG324. In addition to our recent positive AR-13324 phase I findings, including reductions in IOP in individuals who are normotensive, previous phase IIb testing of AR-13324 demonstrated significant IOP lowering in the range of 5.7mmHg to 6.2mmHg in patients with elevated IOP, with consistent IOP lowering across all baseline IOPs tested in the clinical study. We believe that adding latanoprost to AR-13324 in our fixed-combination product has the potential to provide for maximal IOP lowering in patients with glaucoma and ocular hypertension, by targeting all currently known mechanisms of action that affect intraocular pressure."
If approved, Aerie believes that PG324 would be the first glaucoma product to lower IOP through potentially four mechanisms of action: increasing fluid outflow through the trabecular pathway or primary drain, increasing fluid outflow through the uveoscleral pathway or secondary drain, reducing fluid production in the eye and potentially also lowering episcleral venous pressure. The company further believes that PG324, if approved, would be the only glaucoma product that covers the full spectrum of these IOP-lowering mechanisms, thereby providing a greater IOP-lowering effect than any currently approved glaucoma product.
"Aerie has been at the forefront of understanding the unmet needs in glaucoma and exploring new mechanisms of action to effect greater reductions in IOP, which ultimately can help protect and maintain patients' vision," said Vicente Anido, Ph.D., chairman and CEO at Aerie. "Looking forward, we have an aggressive development timeline, with the expectation that in the next 18 months, in addition to reporting the results of our PG324 phase IIb trial, we also will report phase III efficacy data from our AR-13324 program and will have achieved phase III readiness for PG324. With full ownership of these novel products, including IP protection that runs through at least 2030, we are in a very strong position to maximize the value of these programs and further advance toward potential regulatory review and commercialization."