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Non-alcoholic Steatohepatitis (NASH): Update Bulletin #1 [August 2018]

Product Code:
Publication Date:
August 2018

This edition presents key opinion leader (KOL) views on recent developments in the treatment of non-alcoholic steatohepatitis (NASH). Topics covered include expert verdicts on MediciNova’s decision to terminate the Phase II study evaluating tipelukast (MN 001) in the treatment of patients with NAFLD (non-alcoholic fatty liver disease) with hypertriglyceridaemia, in order to accelerate the development of this agent to Phase III. KOLs also give their opinions on Viking Therapeutics’ thyroid beta receptor agonist VK2809 for the treatment of NAFLD and hypercholesterolaemia; topline data from an ongoing Phase II study are expected by the end of 2018. Gemphire Therapeutics’ announcement that positive results from a Phase II study evaluating gemcabene in patients with hypertriglyceridaemia support further development of this agent for the treatment of NAFLD and NASH is also discussed.

Business Questions:

• MediciNova is developing the small molecule therapy tipelukast for the indication of non-alcoholic fatty liver disease (NAFLD), but how optimistic are KOLs regarding the potential of this novel, orally bioavailable product, based on the preclinical and clinical data available to date?
• What safety issues, if any, are associated with tipelukast and do opinion leaders have any concerns as the product moves towards late-stage development?
• At present, there are no approved drugs for the indication of NAFLD/NASH – do KOLs feel that tipelukast could be amongst the first agents to receive such clearance? Could this product be effective as a monotherapy for this indication?
• In June 2018, Viking Therapeutics announced completion of enrolment for a Phase II study evaluating the thyroid beta receptor agonist VK2809 in the treatment of NAFLD with hypercholesterolaemia, but how do KOLs view this novel approach?
• What data are KOLs looking for from VK2809’s Phase II study in order to consider the drug a strong candidate for the treatment of NAFLD/NASH?
• Do KOLs have any safety concerns regarding VK2809, and how can Viking Therapeutics address these issues?
• Does VK2809 have the potential to be a viable monotherapy for the treatment of NAFLD?
• In June 2018, Gemphire Therapeutics announced that positive findings from the Phase IIb INDIGO-1 study evaluating gemcabene for the indication of hypertriglyceridaemia. Do experts believe that this data supports further investigation of the agent in the NAFLD/NASH setting? Do KOLs agree that gemcabene has potential in this indication?
• How do KOLs view Gemphire’s decision to initiate a proof-of-concept study in paediatric patients with NAFLD? What advantages are there to evaluating the drug in this cohort?
• Are there any safety issues with gemcabene that may impact further development of this agent?


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