Finance Associated Press, February 7 (edited by Niu Zhanlin).On Tuesday, local time, the American pharmaceutical giant Eli Lilly and Company announced a fourth-quarter earnings report that exceeded expectations, in addition to the results, Eli Lilly also released some research progress of tirzepatide (tirpatide) in **fatty liver.
Previously, the U.S. Food and Drug Administration (FDA) approved Eli Lilly's tirpatide injection for **, the drug name Zepbound, and approved the drug for tirpatide for **type 2 diabetes mellitus named Mounjaro.
Eli Lilly mentioned in its earnings report that tirpatide showed positive results in a phase II trial called metabolic dysfunction-associated steatohepatitis (MASH).
Fatty liver refers to the lesion of excessive fat accumulation in liver cells caused by various reasons, and is a common pathological change of the liver. More than a quarter of the world's patients have fatty liver disease, and most patients can do it through diet moderation and increased exercise.
MASH is a serious fatty liver disease that poses a threat to global health due to its potential to progress to advanced fibrosis, leading to cirrhosis and liver cancer, but there is currently no drug that can directly mash.
Some studies show that an estimated 3% to 5% of adults in the United States have MASH, and about 11.5 billion people suffer from MASH.
Eli Lilly executives said that the trial followed about 190 patients with MASH, and at all doses, tirpatide met the primary goal of the trial, which is to help patients get rid of the disease, and there was no worsening of liver fibrosis compared with patients who did not receive **.
For example, about 74% of patients who received the highest dose of tirpatide (15 mg)** were free of mash after one year without worsening liver fibrosis, and tirpatide at 10 mg and 5 mg doses also showed significant results. Among patients who received placebo**, the proportion was about 126%。
It is unclear to what extent this drug reduces liver fibrosis, which is one of the goals of Eli Lilly's trial. Eli Lilly did not disclose whether tirpatide met that goal, but the company said the drug's effect in reducing liver fibrosis was "clinically meaningful" at all doses.
Eli Lilly & Company's chief scientific officer, Dan Skovronsky, said at the conference that the company was "equally encouraged" by the results of tirpatide in reducing liver fibrosis. "There's nothing bad in the data that's going to stop us from getting to Phase 3, there's a positive Phase 2 trial in MASH, there's really meaningful data, and it's obligated to think about what's next. ”
Skovronsky claimed that the adverse events were consistent with other studies of tirpatide in obese and diabetic patients, but did not provide further details. Previous trials of zepbound showed that patients experienced negative symptoms such as diarrhoea, nausea and vomiting.
According to Frost & Sullivan, the market volume of mash drugs will exceed $10 billion by 2025, with a compound growth rate of 2019%。
D**id Risinger, an analyst at Leerink Partners, said in a research note that the initial trial results were "positive" and that a larger, longer-term phase 3 trial could show a more significant effect on tirpatide** liver fibrosis.
At the same time, several other drugmakers are also trying to develop the best methods for MASH, although Novo Nordisk's Wegovy and Ozempic interim trials in MASH patients have had mixed results.
Finance Associated Press Niu Zhanlin).