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Shire studies SHP640 for infectious conjunctivitis
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The first U.S. patient has been enrolled in a phase 3 clinical trial for Shire’s SHP640, a combination broad-spectrum antiseptic and corticosteroid being evaluated for treating infectious keratitis in adults and children.
International clinical trial sites are expected to open in the third quarter of 2017, according to an announcement from Shire.
SYNCHRONIZE, the phase 3 trial, will include four multicenter, randomized, double-masked, placebo-controlled studies, with two for adenoviral conjunctivitis and two for bacterial conjunctivitis, the company said.
Shire plans to enroll more than 2,700 patients to investigate the efficacy and safety of SHP640 in adenoviral and bacterial conjunctivitis.
“Infectious conjunctivitis presents a clinical challenge because differentiating between bacterial and adenoviral causes can be problematic due to the considerable overlap in their respective clinical presentations and because current treatment options are limited to bacterial causes only,” David G. Hwang, MD, FACS, said in the release. Hwang is professor and vice chair of ophthalmology and director of the Cornea Service and the Refractive Surgery Service, University of California, San Francisco.
“A single treatment option that could treat both adenoviral and bacterial conjunctivitis and aims to address unnecessary antibiotic use would fulfill an unmet need,” he continued. “SHP640 is a promising candidate in this regard.”
SHP640 is a broad-spectrum antiseptic (povidone-iodine [PVP-I], 0.6%) and anti-inflammatory steroid (dexamethasone, 0.1%) combination. The treatment regimen being studied for SHP640 is one drop, four times per day, for 7 days.
Shire acquired SHP640 (formerly known as FST-100) through the acquisition of Foresight Biotherapeutics Inc. in August 2015.