Are dedicated drug therapies on the way for NASH?
NASH presents a growing health challenge worldwide, particularly as rates of obesity and diabetes spiral. To date, though, there are no drug treatments approved specifically for the disease. Several novel therapies are moving through the mid- to late-stage clinical development. Which of these candidates have the best chance of reaching the market? And how will they be positioned once they get there? Learn how KOLs view the NASH market to come in NASH: KOL Insight (2018).
Twelve US and European KOLs provide candid insights on 20 experimental therapies targeting various aspects of the disease.
- Will Intercept’s obeticholic acid be the first drug to market in NASH? The Phase III REGENERATE trial has delivered encouraging results, even without NASH resolution. But are pruritus and pricing going to restrict uptake?
- How do KOLs rate the next generation of FXR agonists? Are drug candidates from Enanta, Gilead and Novartis sufficiently differentiated, and do they present a serious challenge to obeticholic acid?
- What does Genfit’s elafibranor have to offer? How do KOLs see the drug’s prospects in the Phase III RESOLVE-IT trial and where might elafibranor fit in the NASH treatment paradigm?
- Will dual PPAR targeting do the trick for Zydus’ saroglitazar? What outcomes are KOLs expecting from the Phase III and Phase II EVIDENCES trials in India and the US?
- Is Inventiva’s pan-PPAR approach with lanifibranor the best option for NASH? How do KOLs see the Phase IIb NATIVE study coming out?
- Does Gilead’s selonsertib have any prospects following its STELLAR trial setbacks? Are KOLs surprised by the STELLAR outcomes and do they see a future for selonsertib in combination?
- How do KOLs see the Phase IIb ENCORE trials for emricasan panning out? Is caspase inhibition the way to go in NASH, or will off-target effects prove a barrier to use?
- How do KOLs view VAP-1 inhibition as a targeting mechanism for NASH? How much promise has Boehringer Ingelheim’s BI 1467335 shown in Phase II development?
- Can Tobria’s cenicriviroc pull through in the Phase III AURORA trial following mixed results in Phase II? Is the drug’s best bet as a combination therapy for advanced NASH?
- What do KOLs feel about targeting of liver triglycerides with Galmed’s Aramchol? Are these effects likely to translate into NASH resolution?
- Are the best prospects for Gilead’s GS-0976 in combination? Could raised triglycerides in Phase II be a barrier to further development?
- Can Novo Nordisk’s semaglutide find a place as a NASH treatment? Will the drug be confined to diabetics with NASH, and could injections be a disincentive to use?
- What are KOLs’ expectations for FGFR inhibitors in NASH? BMS-986036 (BMS) and NGM282 (NGM Biopharma) are competing in this space. Which candidate holds the most promise?
- How do KOLs view other novel agents such as Madrigal’s MGL-3196, Can-Fite’s Namodenoson or Immuron’s IMM-124E? Where might they sit in a future treatment algorithm for NASH?
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Enanta Pharmaceuticals
- Galmed Pharmaceuticals
- Genfit Pharmaceuticals
- Gilead Sciences
- IMM 124E Immuron
- Intercept Pharmaceuticals
- Inventiva Pharma
- Madrigal Pharmaceuticals
- Namodenoson Can-Fite BioPharma
- NGM Biopharmaceuticals
- Novo Nordisk
- Tobira Therapeutics
- Zydus Cadila