Acuity Pharmaceuticals starts Cand5 Phase II trial

By Jennifer Chiou

New York, Oct. 14 - Acuity Pharmaceuticals announced it initiated a Phase II C.A.R.E clinical program for lead product candidate Cand5.

Cand5 is for the treatment of wet age-related macular degeneration (wet AMD), which causes adult blindness.

The Phase II study is a randomized, double-masked trial that includes three dose levels of Cand5.

In the Phase I study, the company said Cand5 appeared to be "safe and well tolerated" among 15 patients who were tested at five dose levels. Commonly reported adverse effects included subconjunctival hemorrhage, ocular pain and vitreous floaters.

Acuity's program is the first-ever Phase II program for a small interfering RNA (siRNA) therapy, which is based on the gene silencing technology of RNA interference.

"These encouraging Phase I results, the first data demonstrating the safety of an investigational siRNA drug in humans, indicate that Cand5 is safe and well-tolerated in patients with wet AMD," said Jonathan L. Prenner, an investigator for Acuity's Phase I study, in a news release.

"Cand5's novel RNAi mechanism has the potential to provide important benefits in the treatment of this disabling disease, and we look forward to the results of the Phase II efficacy studies now underway."

Based in Philadelphia, Acuity Pharmaceuticals is an ophthalmic pharmaceutical company.

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