Shire plc announced disappointing results from a phase II study on pipeline candidate SHP607.
The multicenter, randomized, controlled study (ROPP-2008-01) compared experimental protein replacement, SHP607, to the standard neonatal care in 121 premature infants who were born at a gestational age of 23 weeks to 27 weeks plus 6 days. These patients were randomized at birth to receive either SHP607 or the standard neonatal care, and were treated until an equivalent gestational age of 30 weeks.
The study did not meet its primary endpoint of reducing the severity of retinopathy of prematurity (ROP). However, it demonstrated clinically relevant effects in the secondary endpoints related to the development of severe bronchopulmonary dysplasia (BPD), a chronic lung disease, and severe intraventricular hemorrhage (IVH) – a type of brain injury.
Top-line data from the study showed a 53% reduction in the incidence of severe BPD in all patients who received SHP607, as compared to untreated infants. The data also showed an 89% reduction in those who achieved the prespecified target drug exposure. The secondary endpoint of time to discharge from neonatal intensive care was, however, not met.
As per the data provided by the company, approximately 28,000 infants are born extremely premature (before 28 weeks of gestation) in the U.S. According to research, 60% of extremely premature infants experience one or more severe complications related to prematurity, which include: IVH (grade ≥3); BPD; or ROP thereby underscoring the need for treatments for the same.
Consequently, Shire expects to initiate discussions with regulatory authorities about a phase III clinical program focusing on clinically relevant complications of prematurity. Meanwhile, Shire is enrolling patients from the phase II study into a five-year observational long-term outcomes study.
Share price was up on mixed results. Shire has built a deep pipeline in ophthalmology comprising early-, mid- and late-stage candidates gained through organic growth and strategic acquisitions. We remind investors that Shire’s ophthalmic pipeline currently includes candidates for the potential treatment of dry eye disease (lifitegrast), infectious conjunctivitis (SHP640), ROP (SHP607), autosomal dominant retinitis pigmentosa and glaucoma.
Shire currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Pfizer, Inc. (PFE - Free Report) , Bristol-Myers Squibb Co. (BMY - Free Report) and Johnson & Johnson (JNJ - Free Report) . While Pfizer and Bristol-Myers sport a Zacks Rank #1 (Strong Buy), Johnson & Johnson is a Zacks Rank #2 (Buy) stock.
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Shire plc announced disappointing results from a phase II study on pipeline candidate SHP607.
The multicenter, randomized, controlled study (ROPP-2008-01) compared experimental protein replacement, SHP607, to the standard neonatal care in 121 premature infants who were born at a gestational age of 23 weeks to 27 weeks plus 6 days. These patients were randomized at birth to receive either SHP607 or the standard neonatal care, and were treated until an equivalent gestational age of 30 weeks.
The study did not meet its primary endpoint of reducing the severity of retinopathy of prematurity (ROP). However, it demonstrated clinically relevant effects in the secondary endpoints related to the development of severe bronchopulmonary dysplasia (BPD), a chronic lung disease, and severe intraventricular hemorrhage (IVH) – a type of brain injury.
Top-line data from the study showed a 53% reduction in the incidence of severe BPD in all patients who received SHP607, as compared to untreated infants. The data also showed an 89% reduction in those who achieved the prespecified target drug exposure. The secondary endpoint of time to discharge from neonatal intensive care was, however, not met.
As per the data provided by the company, approximately 28,000 infants are born extremely premature (before 28 weeks of gestation) in the U.S. According to research, 60% of extremely premature infants experience one or more severe complications related to prematurity, which include: IVH (grade ≥3); BPD; or ROP thereby underscoring the need for treatments for the same.
Consequently, Shire expects to initiate discussions with regulatory authorities about a phase III clinical program focusing on clinically relevant complications of prematurity. Meanwhile, Shire is enrolling patients from the phase II study into a five-year observational long-term outcomes study.
Share price was up on mixed results. Shire has built a deep pipeline in ophthalmology comprising early-, mid- and late-stage candidates gained through organic growth and strategic acquisitions. We remind investors that Shire’s ophthalmic pipeline currently includes candidates for the potential treatment of dry eye disease (lifitegrast), infectious conjunctivitis (SHP640), ROP (SHP607), autosomal dominant retinitis pigmentosa and glaucoma.
Shire currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Pfizer, Inc. (PFE - Free Report) , Bristol-Myers Squibb Co. (BMY - Free Report) and Johnson & Johnson (JNJ - Free Report) . While Pfizer and Bristol-Myers sport a Zacks Rank #1 (Strong Buy), Johnson & Johnson is a Zacks Rank #2 (Buy) stock.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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