PALO ALTO, CA, USAI January 6, 2016 I Eiger BioPharmaceuticals, Inc. today announced the initiation of enrollment and first patient dosed in LOWR HDV – 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus – 4) at the Hannover Medical School in Hannover, Germany. LOWR HDV – 4 is an open label, dose titration study designed to evaluate the efficacy and tolerability of lonafarnib combined with ritonavir for a total of 24 weeks in fifteen patients with chronic hepatitis delta.
“We are very pleased to participate in our first Phase 2 study involving lonafarnib in hepatitis delta-infected patients,” said Heiner Wedemeyer, MD, Principal Investigator, Research Group Leader in the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School and founding member of the Hepatitis Delta International Network (HDIN). “We are committed to advancing research and to identifying effective therapeutic options for patients infected with HDV, the most aggressive form of chronic viral hepatitis.”
“Dr. Wedemeyer is a long-time advisor to Eiger BioPharmaceuticals and we are proud to involve Hannover Medical School in our development of lonafarnib for HDV,” said Eduardo Martins, MD, DPhil, Senior Vice President of Liver and Infectious Diseases Drug Development at Eiger BioPharmaceuticals. “LOWR HDV – 4 is designed to help elucidate the potential benefits of dose titration as well as the antiviral potential of lonafarnib in combination with ritonavir in a longer duration study.”
About Sarasar® (lonafarnib)
Lonafarnib is a well-characterized, late-stage, orally active inhibitor of farnesyl transferase, an enzyme involved in modification of proteins through a process called prenylation. HDV uses this host cell process inside liver cells to complete a key step in its life cycle. Lonafarnib inhibits the prenylation step of HDV replication inside liver cells and blocks the virus life cycle at the stage of assembly. Since prenylation is carried out by a host enzyme, this compound may present a higher barrier to development of viral resistance mutations. Lonafarnib has been dosed in over 50 HDV-infected patients across international academic centers and is in Phase 2 development for HDV. Lonafarnib has been granted Orphan Drug Designation by the US FDA and European Medicines Agency (EMA), and Fast Track Designation by US FDA. Lonafarnib is not approved for any indication, and is licensed from Merck Sharp & Dohme Corp. (known as MSD outside of the United States and Canada).
About Hepatitis Delta Virus (HDV)
Hepatitis Delta (or Hepatitis D) is caused by infection with HDV and is considered to be one of the most severe forms of viral hepatitis in humans. Hepatitis D occurs only as a co-infection in individuals harboring Hepatitis B Virus (HBV). Hepatitis D leads to more severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, and liver failure. Hepatitis D is a disease with a significant impact on global health, which may affect up to approximately 15 million people worldwide. The prevalence of HDV varies among different parts of the world. Globally, HDV infection is reported to be present in approximately 5-6% of chronic Hepatitis B carriers. The prevalence of HDV in patients infected with chronic HBV is even higher in certain regions, including certain parts of Mongolia, China, Russia, Central Asia, Pakistan, Turkey, Africa, and South America, with an HDV prevalence as high as 60% being reported in HBV-infected patients in Mongolia and Pakistan.
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of Orphan diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed.
SOURCE: Eiger BioPharmaceuticals
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PALO ALTO, CA, USAI January 6, 2016 I Eiger BioPharmaceuticals, Inc. today announced the initiation of enrollment and first patient dosed in LOWR HDV – 4 (LOnafarnib With Ritonavir in Hepatitis Delta Virus – 4) at the Hannover Medical School in Hannover, Germany. LOWR HDV – 4 is an open label, dose titration study designed to evaluate the efficacy and tolerability of lonafarnib combined with ritonavir for a total of 24 weeks in fifteen patients with chronic hepatitis delta.
“We are very pleased to participate in our first Phase 2 study involving lonafarnib in hepatitis delta-infected patients,” said Heiner Wedemeyer, MD, Principal Investigator, Research Group Leader in the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School and founding member of the Hepatitis Delta International Network (HDIN). “We are committed to advancing research and to identifying effective therapeutic options for patients infected with HDV, the most aggressive form of chronic viral hepatitis.”
“Dr. Wedemeyer is a long-time advisor to Eiger BioPharmaceuticals and we are proud to involve Hannover Medical School in our development of lonafarnib for HDV,” said Eduardo Martins, MD, DPhil, Senior Vice President of Liver and Infectious Diseases Drug Development at Eiger BioPharmaceuticals. “LOWR HDV – 4 is designed to help elucidate the potential benefits of dose titration as well as the antiviral potential of lonafarnib in combination with ritonavir in a longer duration study.”
About Sarasar® (lonafarnib)
Lonafarnib is a well-characterized, late-stage, orally active inhibitor of farnesyl transferase, an enzyme involved in modification of proteins through a process called prenylation. HDV uses this host cell process inside liver cells to complete a key step in its life cycle. Lonafarnib inhibits the prenylation step of HDV replication inside liver cells and blocks the virus life cycle at the stage of assembly. Since prenylation is carried out by a host enzyme, this compound may present a higher barrier to development of viral resistance mutations. Lonafarnib has been dosed in over 50 HDV-infected patients across international academic centers and is in Phase 2 development for HDV. Lonafarnib has been granted Orphan Drug Designation by the US FDA and European Medicines Agency (EMA), and Fast Track Designation by US FDA. Lonafarnib is not approved for any indication, and is licensed from Merck Sharp & Dohme Corp. (known as MSD outside of the United States and Canada).
About Hepatitis Delta Virus (HDV)
Hepatitis Delta (or Hepatitis D) is caused by infection with HDV and is considered to be one of the most severe forms of viral hepatitis in humans. Hepatitis D occurs only as a co-infection in individuals harboring Hepatitis B Virus (HBV). Hepatitis D leads to more severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, and liver failure. Hepatitis D is a disease with a significant impact on global health, which may affect up to approximately 15 million people worldwide. The prevalence of HDV varies among different parts of the world. Globally, HDV infection is reported to be present in approximately 5-6% of chronic Hepatitis B carriers. The prevalence of HDV in patients infected with chronic HBV is even higher in certain regions, including certain parts of Mongolia, China, Russia, Central Asia, Pakistan, Turkey, Africa, and South America, with an HDV prevalence as high as 60% being reported in HBV-infected patients in Mongolia and Pakistan.
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of Orphan diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed.
SOURCE: Eiger BioPharmaceuticals
Post Views: 52
