Shire announced the initiation of the phase 3 clinical development program for SHP640, a combination broad spectrum antiseptic and corticosteroid in development for the treatment of infectious conjunctivitis in adults and children. SHP640 is being evaluated for both adenoviral and bacterial conjunctivitis, which are both highly contagious diseases of the ocular surface.
“The initiation of our phase 3 clinical trial program for SHP640 in infectious conjunctivitis marks an important milestone for Shire and our commitment and ability to advance clinical candidates that address areas of significant unmet need in ophthalmics,” Philip J. Vickers, PhD, Head of Research and Development, Shire, said in a company news release. “SHP640 is a strong strategic fit with our ophthalmics portfolio and interest in pursuing treatment options where innovation is needed.”
SYNCHRONIZE, the phase 3 clinical program for SHP640, will include four multicenter, randomized, double-masked, placebo-controlled studies – two for adenoviral conjunctivitis and two for bacterial conjunctivitis. These multicenter studies plan to enroll more than 2,700 patients to investigate the efficacy of SHP640 in adenoviral and bacterial conjunctivitis, and its safety and tolerability. The first patient has been enrolled in the US, with international clinical trial sites expected to open in Q3 2017.
“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, Professor and Vice Chair of Ophthalmology and Director of the Cornea Service and the Refractive Surgery Service, University of California, San Francisco, said in the news release. “A single treatment option that could treat both adenoviral and bacterial conjunctivitis, and aims to address unnecessary antibiotic use, would fulfill an unmet need. SHP640 is a promising candidate in this regard. I commesnd Shire for pioneering a comprehensive research program for this ocular surface condition.
SHP640 is a broad spectrum antiseptic (povidone-iodine [PVP-I], 0.6%), and anti-inflammatory steroid (dexamethasone, 0.1%) combination under investigation for the treatment of adenoviral and bacterial conjunctivitis in adults and children. The treatment regimen being studied for SHP640 is one drop, four times per day, for seven days.
Shire acquired SHP640 (formerly known as FST-100) through the acquisition of Foresight Biotherapeutics in August, 2015.
The phase 2 proof-of-concept efficacy and safety clinical trial program for SHP640 involved two studies in adenoviral conjunctivitis – one three-arm study and another two-arm study. While the two-arm study showed a trend toward efficacy, there were too few subjects testing positive for a viral presence for the study to deliver meaningful results, and it was not statistically significant. In the three-arm study, patients were randomized to receive SHP640, PVP-I, or vehicle 4 times daily for 5 days. Patients treated with SHP640 showed a statistically significant improvement in rates of clinical cure and viral eradication vs. vehicle at Day 6 (30.6% vs. 6.4%, P=0.0033). In the same trial, there was a trend toward clinical significance for SHP640 versus PVP-I (30.6% vs.18.0%, p=0.1432). The most common treatment emergent adverse events in the three-arm Phase 2 study were corneal infiltrates (19%), punctate keratitis (22.4%) and eyelid edema (12.1%). Preclinical experiments were conducted to evaluate bacterial killing speed of SHP640 against pathogens that may cause bacterial conjunctivitis, and the resulting data support further exploration.