Potential for FDA approval nears for emerging NASH therapies
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The emerging treatment landscape of nonalcoholic steatohepatitis has “exploded” as understanding of the pathogenesis grows, according to a presenter at GUILD 2022.
“We [have] a huge armamentarium of drugs in development,” Manal F. Abdelmalek, MD, MPH, professor of medicine and director of the NAFLD Clinical Research Program at Duke University School of Medicine, told attendees. “In my opinion, the future of NASH is going to be binding combination therapies, for which we have a foundation of anti-metabolic therapy, coupled with anti-inflammatory or anti-fibrotic therapy, depending on where patients are in the disease spectrum.”
Abdelmalek noted that liver directed pharmacotherapy should be reserved for patients with NASH and “significant” fibrosis, and that anti-metabolic therapy will be critical in the treatment of NASH.
According to Abdelmalek, there are several drugs in phase clinical 3 trials, including:
- Lanifibranor
- Obeticholic acid
- Semaglutide
- Resmetirom
Among those in phase 2 or phase 2b are:
- Aldafermin
- Cilofexor
- EDP 305
- Efruxafermin
- EYP001
- LMB763
- Px-104
- 89 Bio-100
- Tropifexor
- VK2809
“There is the potential for an FDA subpart approval of a drug, I believe in the upcoming 1 to 2 years, and combination therapy is anticipated to occur in the future,” Abdelmalek said.
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