Eiger pulmonary hypertension 2 phase trial failed to reach the primary endpoint
Eiger pulmonary hypertension 2 phase trial failed to reach the primary endpoint
January 19, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On January 16, Eiger BioPharmaceuticals, a US biotechnology company focused on the development and commercialization of rare disease targeted therapies, announced that the company's drug ubenimex is used in the clinical phase 2 study of pulmonary hypertension (PAH) for LIBERTY at the primary efficacy endpoint for pulmonary vascular resistance. (PVR) and the critical secondary endpoint 6-minute walking distance (6MWD), all patients in the key subgroup failed to achieve improvement. No security issues belonging to ubenimex were found in the preliminary analysis. Although the company will stop the development of PAH for ubenimex based on these results, the company is still further analyzing the data, including biomarker analysis.
Eiger will continue to develop treatments for lymphedema based on the unique mechanism of ubenimex affecting lymphangiogenesis, a study of its mechanism of action published in Science Translational Medicine (Tian et al, May 2017). The clinical study of ubenimex lymphedema includes ULTRA, an international multicenter clinical phase 2 study in patients with primary and secondary lymphedema, with study data expected in the second half of 2018.
David Cory, CEO and President of Eiger, said: "Although we are disappointed with the results of the LIBERTY study, we have always understood that PAH is a complex disease, which is one of our transformation projects. The company has a large number of products for the treatment of rare diseases. The Phase 2 clinical validation test has been confirmed in patients with δ-hepatitis (HDV) infection and post-obesity hypoglycemia (PBH). We are very much looking forward to the end of the Phase 2 trial of HDV with regulatory authorities in February 2018. Communication meeting. The 28-day PREVENT Phase 2 study in PBH patients, together with the top-line results of the ULTRA Phase 2 study in patients with primary and secondary lymphedema, will be reported in the second half of 2018. The company will invest all resources. Advance the development of these important projects."
Eiger is a clinical-stage biopharmaceutical company dedicated to providing innovative products for the treatment of rare diseases. The company has established a diverse product portfolio that has the potential to offer new treatment options for unmet medically demanding, biologically clear and urgently needed innovative therapies. (Sina Pharmaceutical Compilation / David)
Article Reference Source: Eiger BioPharmaceuticals Announces Phase 2 LIBERTY Study in Pulmonary Arterial Hypertension Did Not Meet Primary Endpoint
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