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Non-Alcoholic Steatohepatitis (NASH): Update Bulletin #2 [November 2018]

Product Code:
596201014
Publication Date:
November 2018
Format:
PDF
Price:
£1,140

This edition presents key opinion leader (KOL) views on recent developments in the treatment of non-alcoholic steatohepatitis (NASH). Topics covered include KOL views on Viking Therapeutics’ positive top-line results from a Phase II study investigating the thyroid receptor-beta (TRβ) agonist, VK2809, in patients with non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C);  Bird Rock Bio’s successful completion of a Phase Ib multiple ascending dose trial for nimacimab (RYI-018 or JNJ-2463), a monoclonal antibody (mAb) targeting the cannabinoid-1 (CB1) receptor; and Oramed Pharmaceuticals’ exploratory clinical study investigating the novel orally available insulin therapy ORMD-0801 in the treatment of NASH.

Business Questions:

• How do KOLs view Viking Therapeutics’ top-line data from the Phase II study investigating the thyroid receptor-beta (TRβ) agonist VK2809 in patients with non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C)?
• How confident are opinion leaders that the TRβ receptor pathway has significance in NAFLD/NASH and therefore represents a viable therapeutic target?
• What safety concerns are associated with activation of the TRβ pathway? Viking Therapeutics maintains that VK2809 demonstrates specificity for liver tissues, but how confident are opinion leaders that extra-hepatic effects will not emerge?
• VK2809s Phase II data suggests the product is efficacious in treating NAFLD, but do KOLs believe that VK2809 could be a viable treatment option for the more complex NASH? What evidence does the company need to produce as the product moves into Phase III development?
• As Bird Rock Bio concludes the Phase Ib dose-finding study evaluating the cannabinoid-1 (CB1) receptor inverse agonist nimacimab in NAFLD patients with diabetes or pre-diabetes, what views do KOLs have on this novel mechanism of action?
• As a monoclonal antibody (mAb) with peripheral selectivity for the CB1 receptor are KOLs confident that nimacimab can avoid the serious adverse effects that led to the withdrawal of first-in-class anti-obesity therapy Acomplia (rimonabant; Sanofi Aventis)?
• Could nimacimab’s injectable route of administration be an issue for NAFLD/NASH patients, who are accustomed to orally available treatments?
• Oramed Pharmaceuticals has initiated an exploratory study investigating the orally available insulin therapy ORMD-0801 in the treatment of NASH, but how do KOLs feel about Oramed’s claims that ORMD-0801 has the potential to reduce inflammation in the liver?
• What safety concerns do KOLs have regarding the administration of an insulin therapy to NASH patients?




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