Shire said today that it has acquired Foresight Biotherapeutics for $300 million, in a deal that expands Shire’s pipeline with a late-stage treatment candidate for infectious conjunctivitis (pink eye).
Shire said the candidate, FST-100 (topical ophthalmic drops combining 0.6% povidone iodine (PVP-I) and 0.1% dexamethasone), complements the biotech giant’s late-stage drug candidate for dry eye disease, lifitegrast, and would potentially make the company a leader in treatments for ocular surface conditions.
The deal also reflects shire’s desire to expand its focus on ophthalmic treatments. Shire established its Ophthalmics Business Unit last year, with the goal of addressing unmet needs in eye care. In addition to ocular surface conditions, the company’s ophthalmics pipeline consists of investigational drugs for retinopathy of prematurity, autosomal dominant retinitis pigmentosa, and glaucoma.
Over the past two years, Shire has grown its eye-care business through acquisitions: It bought SARcode Bioscience for $160 million-plus, snapped up Premacure for an undisclosed sum, and acquired Bikam Pharmaceuticals for $2.5 million cash upfront and up to $92 million tied to achieving future development, regulatory, and sales milestones.
“Ophthalmics is a highly-attractive growth area for Shire and this acquisition allows us to strengthen our presence in this therapeutic area,” Shire CEO Flemming Ornskov, M.D., said in a statement. “With the acquisition of Foresight Biotherapeutics, Shire demonstrates its commitment to eye care while advancing its strategy of addressing high unmet medical need through transformative treatments for rare diseases and specialty medicines.”
Upon the close of the deal, Shire has agreed to oversee final development and implementation for a planned Phase III clinical program for FST-100, to also include investigation for the treatment of bacterial conjunctivitis. Foresight Biotherapeutics conducted preclinical experiments evaluating bacterial killing speed of FST-100 against pathogens that may cause bacterial conjunctivitis. The resulting data supported further exploration, according to Shire.
FST-100 was the subject of two studies in adenoviral conjunctivitis comprising a Phase II proof-of-concept efficacy and safety clinical trial program. A two-arm pilot 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 a three-arm study, however, patients treated with FST-100 showed a statistically significant improvement in rates of clinical cure and viral eradication vs. vehicle at Day 6 (30.6% vs. 6.4%), as well as clinically significant improvement in patients using FST-100 versus PVP-I (30.6% vs.18.0%). The most common treatment emergent adverse events were corneal infiltrates (19%), punctate keratitis (22.4%), and eyelid edema (12.1%).
The Phase II clinical data formed the basis of a meeting with the FDA, in which Foresight Biotherapeutics discussed the path forward to conduct a phase III clinical development program for FST-100 as a potential treatment for adenoviral conjunctivitis, Shire said.
If approved by regulators, FST-100 could become the first agent to treat both viral and bacterial conjunctivitis. At present, there is no therapy marketed to treat both clinical signs and symptoms and eradicate the most common cause of viral conjunctivitis, adenovirus. According to Shire, approximately half of infectious conjunctivitis cases have a viral etiology, and 65% to 90% of these are caused by adenovirus.
Under its acquisition agreement, Shire will pay $300 million cash toward the acquisition of Foresight Biotherapeutics. As part of the deal, Shire has acquired global rights to FST-100, adding that it will assess “an appropriate” regulatory filing strategy for ex-U.S. markets.
As for lifitegrast (SHP606), Shire has fully enrolled patients for its Phase III OPUS-3 trial, designed to assess the drug’s safety and efficacy for potential U.S. and overseas regulatory submissions, according to the company’s Form 10-Q quarterly filing on July 31.
OPUS-3 is a multicenter, double-blinded placebo-controlled parallel arm study with a 14-day open-label placebo screening run-in period followed by a 12-week randomized, masked treatment period. The trial’s primary efficacy endpoint is subjective patient-reported symptoms of dry eye, as measured by the eye dryness score, Shire said.