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news.Amicus Therapeutics has presented positive results from its recently completed Phase II clinical trials of Amigal for Fabry disease. Amigal is being developed in partnership with Shire Human Genetic Therapies, a business unit of Shire, which is focused on genetic diseases.
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The primary objective of the Phase II trials was to evaluate the safety and tolerability of treatment with Amigal. The secondary goal was to evaluate certain so-called pharmacodynamic measures of treatment, which refers to the study of the drug’s action or effect on the body. The company said Amigal met this goal.
Amigal was generally safe and well-tolerated at all doses evaluated. No drug-related serious adverse events were reported during the primary treatment arm, and none have been reported during the treatment extension.