Dynavax Technologies Corp., a clinical-stage biopharmaceutical company that discovers and develops novel products to prevent and treat infectious and inflammatory diseases, today announced that it has unblinded its phase 3 primary endpoint immunogenicity data in subjects with chronic kidney disease. The data demonstrates that HEPLISAV achieved statistical significance in both superiority and non-inferiority as compared to Engerix-B.
Dynavax president and Chief Medical Officer Tyler Martin, M.D., detailed HEPLISAV’s performance and what the results mean for future treatment options.
“The demonstrated superiority of HEPLISAV in chronic kidney disease patients who are at high risk of HBV infection and hypo-responsive to hepatitis B vaccine adds to the growing body of evidence of HEPLISAV’s advantages in a well-known hypo-responsive patient population already being vaccinated against hepatitis B infection,” Dr. Martin stated in the press release. “These results, with three doses of HEPLISAV compared to eight doses of Engerix-B, provide the data necessary to support an indication and specific treatment regimen for HEPLISAV in persons with chronic kidney disease.”
The company also conducted a partial safety analysis, which showed a similar safety profile for the HEPLISAV and Engerix-B, with the incidence of post-injection reactions and adverse events similar in both groups. The phase 3, multi-center trial evaluated 507 patients with chronic kidney disease, and compared three doses of HEPLISAV with eight doses of Engerix-B.
The company said it will present detailed results of the trial in November at the American Society of Nephrology Kidney Week meeting in Philadelphia.
For more information visit www.dynavax.com
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