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'We have succeeded in reversing fibrosis in a dramatic way'

Small trial of Israeli drug shows promise for treating fatty liver disease

Fibrosis progressed less than average amount in 15 of the 16 patients enrolled; half of the sample saw their fibrosis go back a stage

Nathan Jeffay is The Times of Israel's health and science correspondent

Illustration of the liver in a woman's body  (Tharakorn via iStock by Getty Images)
Illustration of the liver in a woman's body (Tharakorn via iStock by Getty Images)

An Israeli drug has shown promise for treating fatty liver disease, a common condition for which there is no US Food and Drug Administration-approved medical therapy.

Tel Aviv-based Galmed Pharmaceuticals has just announced that a the first results from the Phase 3 study for its drug Aramchol, the product of more than 20 years of work, have shown positive results.

The results are from 16 patients, all of who had fibrosis, meaning abnormally large amounts of scar tissue in the liver, which happens in the advanced stages of the disease.

They were part of an open label study — research in which medical staff and patients knew what drug they were receiving — which concluded that fibrosis progressed less in 15 of the 16 patients enrolled than in the average patient. This study is one component of the Phase 3 testing, which involves 150 people in total.

“Fatty liver diseases progresses to fibrosis and this is a problem because you can then end up with liver failure or increased risk of mortality, which is why slowing the advancement of fibrosis is the holy grail of addressing the disease,” Allen Baharaff, president and CEO of Galmed, told The Times of Israel.

3D illustration of a diseased liver (iStock via Getty Images)

“We are excited because we have succeeded in reversing fibrosis in a dramatic way.”

Allen Baharaff, president and CEO of Galmed Pharmaceuticals (Arkadi Raskin)

Liver fibrosis is measured in four stages, and the study found that half of the patients given Aramchol improved by one stage or more. In unrelated studies that examined patients who were not treated, only 10% to 20% showed similar improvement.

Nasdaq-traded Galmed has attracted significant investment for the development of the drug, with $18.4 million raised in February.

Baharaff said that he expects to start a 1,000-patient double-blind study next year, and is hoping that the drug will be approved by the FDA in 2024.

“We view the most recent data as a game-changer for the company and more importantly for the treatment of fatty liver disease,” he said.

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