Sagimet Biosciences’ SGMT stock rose 12.6% on Tuesday after it announced that the FDA has granted breakthrough therapy designation (“BTD”) to its lead pipeline candidate, denifanstat, for treating noncirrhotic metabolic dysfunction-associated steatohepatitis (“MASH”), a progressive and severe liver disease.
The BTD is for treating MASH in patients who have moderate-to-advanced liver fibrosis (consistent with stage F2 and F3 disease). MASH is also called nonalcoholic steatohepatitis or NASH.
The FDA grants BTD to expedite the development and review of therapies for severe or life-threatening diseases where preliminary clinical evidence shows that the therapies may provide substantial improvements over available treatments.
The FDA’s BTD for denifanstat, an oral, once-daily pill, in patients with MASH was based on positive data from the phase IIb FASCINATE-2 study in biopsy-confirmed MASH patients with stage 2 or stage 3 fibrosis. Data from the study demonstrated denifanstat’s statistically significant fibrosis reduction in advanced F2 and F3 patients and a statistically significant delay in progression to cirrhosis. Sagimet plans to initiate a phase III program for denifanstat for MASH by the end of 2024
Sagimet Biosciences stock has risen 9.5% in the past three months compared with an increase of 8.8% for the industry.
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MDGL’s Rezdiffra is the Only Approved Drug for MASH
Currently the only approved treatment for MASH is Madrigal Pharmaceuticals’ MDGL Rezdiffra (resmetirom), which is approved for treating noncirrhotic MASH and moderate-to- advanced liver fibrosis. Madriga’s Rezdiffra, a once-daily, oral thyroid hormone receptor beta-selective agonist, was approved by the FDA in the United States in March this year and launched in April. A regulatory application seeking the approval of resmetirom is currently under review in the EU. A final decision is expected in mid-2025. Several late-stage studies are ongoing to evaluate the expanded use of resmetirom for NASH.
NASH affects more than 115 million people worldwide. It can progress to severe conditions like cirrhosis, liver failure, or liver cancer, often necessitating liver transplantation. As NASH advances to moderate or severe fibrosis (stages F2 and F3), the risk of adverse liver outcomes rises significantly. The vast and diverse NASH market is untapped, creating a significant need for novel therapies. Denifanstat is the only fat synthesis inhibitor that directly targets the three main drivers of MASH, fat accumulation, inflammation, and fibrosis, which Sagimet claims differentiates denifanstat from other therapeutics in MASH.
VKTX, AKRO, NVO, LLY Making Drugs for MASH
There are several other companies like Viking Therapeutics VKTX, Akero Therapeutics AKRO, Eli Lilly and Novo Nordisk, which are currently developing treatments for NASH/MASH.
Viking is developing its investigational candidate, VK2809, for biopsy-confirmed NASH and fibrosis. The company’s mid-stage study evaluating the safety and efficacy of VK2809 has already met its primary and secondary endpoints with statistical significance. Akero Therapeutics is evaluating its lead candidate, efruxifermin, for treating MASH across multiple clinical studies.
Eli Lilly’s highly successful dual GIP and GLP-1 receptor agonist, tirzepatide, is also being evaluated in mid-stage studies for NASH. Novo Nordisk is also evaluating its diabetes and obesity GLP-1 drug, semaglutide, in a late-stage study for NASH.
SGMT’s Zacks Rank
Sagimet Biosciences has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sagimet Biosciences Inc. Price and Consensus
Sagimet Biosciences Inc. price-consensus-chart | Sagimet Biosciences Inc. Quote
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