PALO ALTO, CA, USA I October 16, 2018 I Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare diseases, today announced Phase 2 ULTRA study results in primary and secondary lymphedema of the lower limb demonstrated no improvement of ubenimex over placebo in the primary endpoint of skin thickness and secondary endpoints of limb volume and bioimpedance. No safety signals attributed to ubenimex were identified.
Topline analysis suggests select, individual patient responses which clinical investigators believe warrant further exploration. The company plans no additional clinical work but will support these additional investigator analyses and will update if future findings suggest any potential pathway forward. Eiger would pursue such an option only through a strategic partnership.
“Eiger is advancing only the most promising programs in our pipeline for rare diseases,” said David Cory, President and CEO. “The company is now focused on advancing plans for a new drug application (NDA) in Progeria, enrollment in the first-ever Phase 3 study in hepatitis delta virus (HDV) infection, and regulatory guidance in post-bariatric hypoglycemia (PBH) in 2019.”
About Eiger
Eiger is a clinical-stage biopharmaceutical company focused on the accelerated development and commercialization of targeted therapies for rare and ultra-rare diseases. We innovate by developing well-characterized drugs acting on newly identified or novel targets in rare diseases. Our mission is to systematically reduce the time and cost of the drug development process to more rapidly deliver important medicines to patients. Lonafarnib is our lead compound advancing into Phase 3 with a single, pivotal trial to treat HDV to initiate by the end of the year. Lonafarnib is also advancing toward an NDA for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) in 2019. For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
SOURCE: Eiger BioPharmaceuticals
Post Views: 26
PALO ALTO, CA, USA I October 16, 2018 I Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare diseases, today announced Phase 2 ULTRA study results in primary and secondary lymphedema of the lower limb demonstrated no improvement of ubenimex over placebo in the primary endpoint of skin thickness and secondary endpoints of limb volume and bioimpedance. No safety signals attributed to ubenimex were identified.
Topline analysis suggests select, individual patient responses which clinical investigators believe warrant further exploration. The company plans no additional clinical work but will support these additional investigator analyses and will update if future findings suggest any potential pathway forward. Eiger would pursue such an option only through a strategic partnership.
“Eiger is advancing only the most promising programs in our pipeline for rare diseases,” said David Cory, President and CEO. “The company is now focused on advancing plans for a new drug application (NDA) in Progeria, enrollment in the first-ever Phase 3 study in hepatitis delta virus (HDV) infection, and regulatory guidance in post-bariatric hypoglycemia (PBH) in 2019.”
About Eiger
Eiger is a clinical-stage biopharmaceutical company focused on the accelerated development and commercialization of targeted therapies for rare and ultra-rare diseases. We innovate by developing well-characterized drugs acting on newly identified or novel targets in rare diseases. Our mission is to systematically reduce the time and cost of the drug development process to more rapidly deliver important medicines to patients. Lonafarnib is our lead compound advancing into Phase 3 with a single, pivotal trial to treat HDV to initiate by the end of the year. Lonafarnib is also advancing toward an NDA for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) in 2019. For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
SOURCE: Eiger BioPharmaceuticals
Post Views: 26
