Akero is on track to report 36-week treatment data from the phase IIb SYMMETRY main study, evaluating EFX in adult patients with cirrhotic NASH in fourth-quarter 2023. Based on this data, Madrigal initiated a rolling new drug application (NDA) submission last month seeking accelerated approval for resmetirom to treat NASH with liver fibrosis.Īkero Therapeutics is evaluating its lead candidate efruxifermin (EFX) for treating NASH. The study achieved its primary endpoints and potentially clinically meaningful effects compared with placebo. Last December, Madrigal reported positive top-line data from the pivotal phase III MAESTRO-NASH study evaluating its resmetirom for treating NASH and liver fibrosis. Madrigal Pharmaceuticals is developing its lead candidate resmetirom for treating NASH and liver fibrosis. While the NASH market holds potential with no approved therapies yet, it is challenging as several companies like Madrigal Pharmaceuticals MDGL and Akero Therapeutics AKRO are trying to develop a successful treatment for the same. NASH is a progressive form of non-alcoholic fatty liver disease, characterized by excessive fat buildup in the liver, accompanied by inflammation and fibrosis, which may progress to cirrhosis, liver failure, cancer and death. Management plans to report 52-week treatment data from this study in first-half 2024. In fact, 85% of patients who received VK2809, experienced at least a 30% relative reduction in liver fat content. The VOYAGE study achieved its primary endpoint of statistically significant reduction in liver fat content in NASH patients following 12 weeks of treatment with VK2809. In May, Viking Therapeutics reported positive data from an ongoing phase IIb study (VOYAGE) evaluating VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (“NASH”). Shares of Viking Therapeutics suffered a negative impact following Lilly’s announcements. LLY also completed the regulatory submission seeking label expansion for its dual GIP/GLP-1-RA drug tirzepatide to treat obesity or overweight in adults, with a final decision expected before this year’s end. Last month, Lilly reported new data from multiple mid-stage studies, evaluating different obesity drug that achieved a mean weight reduction of up to 24%. Eli Lilly is running multiple comprehensive clinical development programs evaluating different drugs for treating obesity in patients, with or without diabetes, which can be administered orally or by injections. The initiation is likely in response to the ongoing obesity drug wave wherein several large-cap pharma companies like Eli Lilly LLY, Novartis and Pfizer are evaluating oral formulations for treating obesity.Įarlier this year, several pharma companies reported positive data from multiple studies evaluating their obesity drugs. Based on these results, Viking intends to start a phase II study evaluating VK2735 to treat patients with obesity by mid-2023.īased on the results, Viking Therapeutics initiated an early-stage extension study to evaluate the oral formulation of VK2735 with highly-differentiated dosing options in healthy adults. Management also believes that the tolerability data from this study suggest that higher doses of VK2735 may be achieved with longer titration windows. Data from the study demonstrated up to 6% placebo-adjusted mean weight reduction (7.8% from baseline), following 28 days of treatment with VK2735. In March, Viking Therapeutics reported encouraging data from the recently completed early-stage clinical study evaluating its dual GIP/GLP-1-RA drug VK2735 administered subcutaneously across various metabolic disorders. The upside can be attributed to the successful development of its pipeline candidates targeting various metabolic and endocrine disorders.
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