Genes that control percentage of body fat are also responsible for circulating levels of testosterone in men, research published in the latest edition of Clinical Endocrinology shows. The research shows a 23% overlap between the genes that control testosterone and those that regulate body fat composition, suggesting that these two variables are partly controlled by the same set of genes.
Amicus Therapeutics (Nasdaq: FOLD), a biopharmaceutical company developing small molecule, orally-administered pharmacological chaperones for the treatment of human genetic diseases, announced that it has successfully completed an End of Phase 2 meeting for Amigal(TM) with the U.S. Food and Drug Administration (FDA). The FDA indicated that the data from the completed Phase 2 clinical studies of Amigal support the start of Phase 3 development and agreed that Amigal meets the criteria to be considered for accelerated approval. The Agency further indicated that it is not opposed to the use of a surrogate primary endpoint, pending further discussion and final agreement on the Phase 3 trial design.
