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news.Quark Pharmaceuticals has announced that its partner, Pfizer has initiated patient dosing in a Phase II trial evaluating PF-4523655 in patients with diabetic macular edema.
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The Phase II prospective, randomized, dose-ranging study is evaluating the safety and efficacy of PF-4523655 versus laser therapy in 160 diabetic macular edema (DME) patients at multiple centers worldwide.
Eligible patients will be randomized to receive intravitreal injections of one of three dose levels of PF-04523655 or laser. Therapeutic effect will be evaluated through visual acuity and retina morphological examinations conducted over a 36-month follow up period.
PF-4523655 was designed to inhibit Quark’s proprietary target RTP801, a gene involved in abnormal blood vessel development and leakage in the eye.
PF-4523655 is a novel siRNA drug candidate being co-developed by Quark and Pfizer. As part of the companies’ global licensing agreement, the successful commencement of the trial triggers a milestone payment to Quark from Pfizer, a small percentage of which is payable by Quark to Silence Therapeutics and Alnylam as technology license milestone payments.
Shai Erlich, chief development officer of Quark, said: “We look forward to continuing our relationship with Pfizer throughout later stages of clinical development and intend to fully collaborate towards the potential commercialization of PF-4523655 in diabetic macular edema, age-related macular degeneration, and other ophthalmic indications covered in our agreement.”