FDA grants fast track designation to oral testosterone prodrug for treatment of NASH
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The FDA granted fast track designation to LPCN 1144 as a treatment for non-cirrhotic nonalcoholic steatohepatitis, according to a release from Lipocine.
“The granting of fast track designation represents an important recognition by the FDA of LPCN 1144’s potential to address a significant unmet need in the treatment of NASH,” Mahesh Patel, PhD, chairman, president and CEO of Lipocine, said in the release. “We believe the fast track designation will enable us to work closely with the FDA on our development program for NASH, including the design of the phase 3 program.”
According to the release, the oral prodrug of bioidentical testosterone was recently assessed in the LiFT phase 2 paired-biopsy clinical study in patients with NASH. There was significant liver fat reduction noted in patients treated with LPCN 1144 as well as improvements in liver injury markers. There were no tolerability issues observed.
In addition, after 36 weeks of treatment with LPCN 144 compared with placebo, patients met the NASH resolution regulatory endpoints, showed positive impact in appendicular lean mass and whole-body fat mass and continued to demonstrate substantial reductions in markers of liver injury.
Perspective
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Jamile’ Wakim-Fleming, MD, FACG, FAASLD
It is known that multifactorial causes contribute to the development of metabolic syndrome and fatty liver disease. One of these causes is hormonal factors. Testosterone is a hormone produced by Leydig cells in the testes in men and it is modulated by hypothalamus-pituitary levels. Studies and meta-analysis have shown that low levels of testosterone are associated with fatty liver in men but inversely for women. Other studies have shown the benefit of testosterone in improving NASH and fibrosis in men.
Treatment of fatty liver and NASH remain limited, but the population that has fatty liver disease is rapidly increasing. Hence, there is a dire need to develop drugs that improve NASH and fibrosis among patients with fatty liver disease.
Testosterone, due to its beneficial effects on fatty liver in men, could be the drug that helps manage this disease and prevent its complications. The FDA just granted a fast-track designation to an oral testosterone prodrug for the treatment of NASH. This is a very encouraging move and will allow more studies that have the potential to verify the drug’s efficacy and safety. That said, more drug trials are needed for both men and women.
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