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Eton Pharmaceuticals, Inc. (Nasdaq: ETON) said the first patient has been dosed in a pilot clinical study evaluating ET-700, its proprietary extended-release zinc acetate formulation, for the treatment of Wilson disease. The company expects topline results in the second half of 2026, and if those results are positive, it plans to move to a pivotal clinical study in early 2027.
The study is being conducted by the Department of Hepatology and Gastroenterology at Aarhus University Hospital in Denmark. It is a double-blinded, placebo-controlled trial involving 36 healthy volunteers randomly assigned to one of three treatment groups.
Researchers will use positron emission tomography (PET) imaging with the radioactive tracer 64CuCl2 (64-copper dichloride) to assess intestinal copper absorption. Participants will receive:
The treatment period will last four weeks. PET scans will assess intestinal copper absorption by measuring the amount of 64Cu in the liver. The primary endpoint is the change in mean hepatic 64Cu standard uptake value from pre- to post-intervention between the three groups, as determined by two blinded investigators.
Sean Brynjelsen, CEO of Eton Pharmaceuticals, said ET-700 could represent a meaningful advancement for patients with Wilson disease by exploring a more convenient and simpler dosing approach for a lifelong chronic therapy. He added that, if approved, the company believes ET-700 could exceed $100 million of peak annual sales in the United States.
Study investigator Dr. Thomas Sandahl, Clinical Professor of Hepatology at Aarhus University, said the trial will use 64Cu PET imaging to evaluate whether an extended-release zinc formulation can reduce intestinal copper absorption with a simpler dosing regimen.
Galzin (zinc acetate) is indicated for maintenance treatment of patients with Wilson’s disease who have been initially treated with a chelating agent.
Contraindication: Hypersensitivity to zinc acetate or any ingredients in Galzin.
Warnings and precautions: Post-marketing cases have reported that zinc acetate taken over extended periods may decrease enteral copper absorption and lead to copper deficiency. If copper deficiency signs or symptoms develop, zinc treatment should be interrupted and zinc, 24-hour urinary copper, and non-ceruloplasmin bound copper (NCC) levels should be measured.
Gastric ulcers, including complications such as anemia and gastric ulcer perforation with peritonitis, have been reported with long-term use of zinc acetate.
General: Galzin is not recommended for initial therapy of symptomatic patients due to the delay required for zinc-induced increases in enterocytic metallothionein and blockade of copper uptake. During initial therapy, neurological deterioration may occur as copper stores are mobilized.
Common adverse reactions: Gastric irritation, elevations of serum alkaline phosphatase, amylase, and lipase suggesting pancreatitis.
Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently has ten commercial rare disease products: KHINDIVI, INCRELEX, ALKINDI SPRINKLE, DESMODA, GALZIN, HEMANGEOL, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous, and Nitisinone. Eton also has four additional product candidates in late-stage development: Amglidia, ET-700, ET-800 and ZENEO hydrocortisone autoinjector.
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