– End of Phase 2 Meeting Scheduled for HDV in February 2018
– Phase 2 Readouts for PBH and Lymphedema in Second Half 2018
PALO ALTO, CA, USA I January 16, 2018 I Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare diseases, announced today Phase 2 LIBERTY study results in pulmonary arterial hypertension (PAH) that demonstrated no improvement overall or in key subgroups for both the primary efficacy endpoint of pulmonary vascular resistance (PVR) and the secondary endpoint of 6-minute walk distance (6MWD). No safety signals attributed to ubenimex were identified in the preliminary analysis. Further analysis of data, including biomarkers is ongoing, although the company will discontinue development of ubenimex in PAH based on these results.
Eiger will continue to develop ubenimex for lymphedema based on its distinct mechanism of action impacting lymphangiogenesis as published in Science Translational Medicine (Tian et al, May 2017). Eiger is developing ubenimex for lymphedema in the ULTRA study, a multi-center, international, Phase 2 study in patients with primary and secondary lymphedema that is fully enrolled with data expected in the second half of 2018.
“While we are disappointed with results from the LIBERTY study, we have always recognized that PAH is a complex disease and that this was a translational program,” said David Cory, President and CEO. “Eiger has a deep pipeline of products focused on rare diseases that was built to reduce risk against a single binary event. Phase 2 proof of concept has already been demonstrated in both Hepatitis Delta Virus (HDV) Infection and Post-Bariatric Hypoglycemia (PBH). We look forward to our upcoming End of Phase 2 meeting for HDV with the agency in February 2018. Topline results from the Phase 2, 28 day PREVENT study in PBH as well as for the Phase 2 ULTRA study in primary and secondary lymphedema will be reported in the second half of 2018. The company will direct all resources to advance these important efforts.”
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare 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: 258
– End of Phase 2 Meeting Scheduled for HDV in February 2018
– Phase 2 Readouts for PBH and Lymphedema in Second Half 2018
PALO ALTO, CA, USA I January 16, 2018 I Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare diseases, announced today Phase 2 LIBERTY study results in pulmonary arterial hypertension (PAH) that demonstrated no improvement overall or in key subgroups for both the primary efficacy endpoint of pulmonary vascular resistance (PVR) and the secondary endpoint of 6-minute walk distance (6MWD). No safety signals attributed to ubenimex were identified in the preliminary analysis. Further analysis of data, including biomarkers is ongoing, although the company will discontinue development of ubenimex in PAH based on these results.
Eiger will continue to develop ubenimex for lymphedema based on its distinct mechanism of action impacting lymphangiogenesis as published in Science Translational Medicine (Tian et al, May 2017). Eiger is developing ubenimex for lymphedema in the ULTRA study, a multi-center, international, Phase 2 study in patients with primary and secondary lymphedema that is fully enrolled with data expected in the second half of 2018.
“While we are disappointed with results from the LIBERTY study, we have always recognized that PAH is a complex disease and that this was a translational program,” said David Cory, President and CEO. “Eiger has a deep pipeline of products focused on rare diseases that was built to reduce risk against a single binary event. Phase 2 proof of concept has already been demonstrated in both Hepatitis Delta Virus (HDV) Infection and Post-Bariatric Hypoglycemia (PBH). We look forward to our upcoming End of Phase 2 meeting for HDV with the agency in February 2018. Topline results from the Phase 2, 28 day PREVENT study in PBH as well as for the Phase 2 ULTRA study in primary and secondary lymphedema will be reported in the second half of 2018. The company will direct all resources to advance these important efforts.”
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare 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: 258
