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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (50710)	1/31/2019 3:04:42 PM
From: oldirtybastard	1 Recommendation Recommended By Biotech Jim Respond to of 52153

here's the info, not super easy to find directly, along with some on prior trials linked below FALCON 1 is NCT03486899 aka MB130-068 FALCON 2 is MB130-069 aka NCT03486912 med.umich.edu BMS FALCON 1: A phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of BMS-986036 (PEG-FGF21) in adults with nonalcoholic steatohepatitis (NASH) and stage 3 liver fibrosisSponsor: Bristol-Myers Squibb Research and DevelopmentEnrollment status: OPENObjectiveThe purpose of this research study is to measure how effective and how safe BMS-986036 is in treating patients with nonalcoholic steatohepatitis (NASH) and stage 3 liver fibrosis. Inclusion criteriaAdultsConfirmed diagnosis of NASH with advanced fibrosis (score of 3 based on NASH–CRN)Exclusion criteriaOther liver diseaseCurrent or past history of decompensated cirrhosisVarices on EGDStudy designEligible patients will be randomized 1:1:1:1 to receive 10 mg once weekly of BMS-986036, 20 mg once weekly of BMS-986036, 40 mg once weekly of BMS-986036 or a placebo for 1 yearPatients will be monitored for response and for side effectsResponse will be assessed using paired liver biopsies, before and after treatmentStudy will provide medications and cover costs of tests. Compensation for time will be provided. Principal investigator: Anna Lok, MD, aslok@med.umich.edu Contact person: Sravanthi Kaza, (734) 615-3853 or sravanth@med.umich.edu BMS FALCON 2: A phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of BMS-986036 (PEG-FGF21) in adults with nonalcoholic steatohepatitis (NASH) and compensated liver cirrhosisSponsor: Bristol-Myers Squibb Research and DevelopmentEnrollment status: OPENObjectiveThe purpose of this research study is to measure how effective and how safe BMS-986036 is in treating participants with nonalcoholic steatohepatitis (NASH) and compensated liver cirrhosis. Inclusion criteriaAdultsConfirmed diagnosis of NASH and cirrhosis based on NASH–CRNExclusion criteriaOther liver diseaseCurrent or past history of decompensated cirrhosisVarices on EGDStudy designEligible patients will be randomized 1:1:1:1 to receive 10 mg once weekly of BMS-986036, 20 mg once weekly of BMS-986036, 40 mg once weekly of BMS-986036 or a placebo for 1 yearPatients will be monitored for response and for side effectsResponse will be assessed using paired liver biopsies, before and after treatmentStudy will provide medications and cover costs of tests. Compensation for time will be provided. Principal investigator: Anna Lok, MD, aslok@med.umich.edu Contact person: Sravanthi Kaza, (734) 615-3853 or sravanth@med.umich.edu http://www.natap.org/2018/EASL/EASL_81.htm http://natap.org/2017/AASLD/AASLD_139.htm