Slightly more than one year after reporting 12-week data from its Phase IIb VOYAGE trial showing that VK-2809 can significantly reduce liver fat content in metabolic-associated steatohepatitis (MASH), Viking Therapeutics, Inc. bolstered those findings on 4 June with 52-week, histologic data from the study that also demonstrated a statistically significant benefit on reducing fibrosis.
Key Takeaways
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Viking reports 52-week biopsy data for VK2809 in MASH, bolstering the case made with 12-week data in 2023 for MASH resolution with the drug.
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The company still prefers to move into Phase III with a partner and place its main emphasis on obesity candidate VK2735
The data position the San Diego-based firm to seek an end-of-Phase II meeting with the US Food and Drug Administration during the second half of 2024 to work out the details of a potential Phase III program for VK2809, a thyroid hormone receptor beta (THRβ) agonist. VK2809 is from the same drug class as Madrigal Pharmaceuticals, Inc.’s Rezdiffra (resmetirom), the first approved MASH therapy, but Viking has worked to differentiate its candidate as offering greater potency and a better safety and tolerability profile
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