GlaxoSmithKline ($GSK) got some good news for its big vaccines group, scoring a pivotal Phase III win for its shingles vaccine HZ/su more than four years after the study was launched.
The herpes zoster jab reduced the risk of shingles by 97.2% in a crowd of patients in the 50-plus age group. And the outcome marks the end of a trial that was launched way back in 2010 as investigators recruited 16,000 people in 18 countries. The full Phase III program includes 37,000 people.
HZ/su combines a protein found in the virus along with an adjuvant to amp up its effect. And GlaxoSmithKline has mounted numerous clinical trials to demonstrate its efficacy and safety. Part of that effort is being devoted to a study of people aged 70-plus. And there's additional work underway to determine the vaccine's ability to prevent complications of shingles, including neuropathic pain.
The varicella-zoster virus causes shingles, a painful skin rash that the CDC says afflicts about a million people a year in the U.S.
The pharma giant has been beefing up its vaccines operation as it reorganizes its global business. The numbers have been deteriorating at GSK as franchise drugs lose patent protection and its newer therapies have been slow to catch on. The company is currently completing a massive swap with Novartis ($NVS), gaining the Swiss company's vaccines operation in exchange for a portfolio of cancer drugs.
"It's great news that the ZOE-50 trial has met its primary endpoint and I would like to thank all those involved in the clinical development program," says GSK vaccine development chief Alain Brecx. "If approved, this candidate vaccine may offer an important option for the prevention of shingles, a painful disease that negatively impacts peoples' health and quality of life. We look forward to sharing these compelling results and additional data from the ZOE-50 study and the broader HZ/su clinical development program with the scientific and regulatory communities."
- here's the release