Viking Therapeutics saw its stock rise and fall upon positive Phase I data but analyst manufacturing concerns. Image credit: Roman Kybus / Shutterstock

Shares in Viking Therapeutics jumped after the company shared positive data from an early-stage trial of its obesity pill but then dipped after an analyst shared concerns about manufacturing difficulties with the drug.

The Phase I study (NCT05203237), evaluating VK2735, reported a placebo-adjusted weight loss of 6.8% in the high-dose cohort after four weeks in 92 patients. The company announced the positive data for the dual glucagon-like peptide-1 receptor (GLP-1R)/gastric inhibitory polypeptide (GIP) receptor agonist at ObesityWeek 2024, taking place in Texas, US, from 3 to 6 November.

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The trial investigated eight doses of the drug, ranging from 2.5mg to 100mg versus a placebo. The majority of adverse events were mild or moderate, with four patients on Viking’s drug and two on placebo discontinuing the trial.

Viking Therapeutics said it will begin a 13-week Phase II study of its oral candidate in Q4 2024.

The company’s shares rose by 7.44%, from a close of $72.88 on 1 November to an open of $78.30 on 4 November after the company shared the positive data. It then fell by 19.36% before market close after Deutsche Bank analyst James Shin said it could be “costly with capital requirements and expertise” beyond major competitors, reports Reuters.

Last month, Viking CEO Brian Lian claimed the company is in conversations with manufacturers to ensure a “blockbuster” supply.

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Subcutaneous version more advanced

Viking also revealed more data from its Phase II study of a subcutaneous version of VK2735. The 13-week VENTURE study (NCT06068946) showed a mean weight loss of 14.7% or 13.1% adjusted for placebo, in the high dose cohort.

The company announced mid-stage data from the VENTURE study in February 2024 which sent the company’s stock price soaring by 80%. The mid-stage data showed average weight losses of 9.2kg, 10.7kg, 13.3kg, 14.6kg, and 1.8kg in the 2.5mg, 5mg, 10mg, 15mg, and placebo groups, respectively.

The company was previously considering a Phase IIb trial but after sharing such positive data, it will be progressing straight to a Phase III trial after receiving the green light from the US Food and Drug Administration (FDA).

According to GlobalData, both oral and subcutaneous versions of VK2735 could become a direct competitor to Eli Lilly’s Mounjaro (tirzepatide), the only dual GLP-1/GIP receptor agonist currently approved.

GlobalData is the parent company of the Clinical Trials Arena.

The weight loss field is heavily dominated by glucagon-like peptide 1 receptor agonists (GLP-1ra’s), with Eli Lilly’s drug and Novo Nordisk’s semaglutide being the front runners. Semaglutide, marketed at Ozempic for type 2 diabetes (T2D) and Wegovy for obesity is predicted to raise $42.85bn in sales in 2030, according to GlobalData. Meanwhile, Eli Lilly’s candidate, marketed as Mounjaro for T2D and Zepbound for obesity, is predicted to bring in £57.65bn in the same year.