Ascletis Pharma is going all-in on metabolic disease. Responding to the progress of its obesity pipeline, the Chinese biotech is stepping up its investment in metabolic disease clinical trials while rapidly retreating from the antiviral, oncology and liver programs that were once at the heart of its strategy.
Antiviral, cancer and liver disease drug candidates were central to Ascletis’ strategy when the company went public in 2018. However, the biotech suffered setbacks in the clinic in its original core areas, leading it to ax hepatitis B and liver disease programs. More recently, Ascletis has unveiled and quickly advanced a weight-loss pipeline that features oral and subcutaneous formulations of a GLP-1 receptor agonist.
Ascletis formalized the shift in its priorities in its full-year results (PDF) Wednesday. Last year, the biotech allocated 33.7% of its budget to the development of treatments for viral diseases such as hepatitis and HIV. This year, Ascletis is slashing viral diseases’ share of the budget to 0.4%.
The dramatic drop in funding for viral disease R&D reflects the termination of three programs. Ascletis is stopping work on ASC22 as a functional cure for chronic hepatitis B and HIV while also pulling the plug on development of ASC10 in respiratory syncytial virus. Continued R&D of ASC22 and pipeline products in other viral diseases accounts for the 0.4% of spending Ascletis has earmarked for that once-core area.
A similar story is playing out in Ascletis’ liver disease pipeline. The company has decided against taking its thyroid hormone receptor beta agonist into a phase 3 metabolic dysfunction-associated steatohepatitis trial. Ascletis plans to further assess its primary biliary cholangitis prospect and seek opportunities to maximize the value of the program. Liver diseases’ share of spending will fall from 6.3% to 3.2%.
Ascletis is also cutting spending on oncology, slashing its share of the budget from 13.9% to 4.3%. The biotech plans to seek opportunities to maximize the value of its glioblastoma prospect ASC40 as well as its solid tumor candidate ASC61, which Ascletis wants to out-license.
The biotech’s thinning of its antiviral, oncology and liver disease pipelines will free up cash to spend on obesity and other metabolic diseases. Last year, Ascletis didn’t even list metabolic disease in its spending plan, instead bundling the therapeutic area in with other “new pipeline drug candidates.” The candidates collectively accounted for 30.8% of Ascletis’ spending last year.
In 2025, metabolic disease R&D will swallow up 63.6% of the budget. Ascletis has set aside 18.6% of the budget for R&D involving new pipeline drug candidates. Six months after announcing (PDF) its entry into the obesity space, Ascletis has almost completely reorientated its budget around metabolic diseases at the expense of all of its long-standing core therapeutic areas.
The wholesale switcheroo follows the publication of obesity data. Ascletis linked its oral GLP-1 to 6.3% mean weight loss after 28 days, suggesting—with big caveats around cross-trial comparisons—that the candidate could have market-leading efficacy. The biotech plans to publish interim data on the injectable GLP-1 this month. The obesity pipeline also includes thyroid hormone receptor beta agonist ASC47.
This year, Ascletis is aiming to start a 13-week phase 2a trial of its oral GLP-1, share topline results from a phase 1b trial of its subcutaneous GLP-1 and complete a trial of ASC47 in combination with semaglutide, Novo Nordisk’s GLP-1 drug. Ascletis is based in China but all those trials are enrolling patients in the U.S.