Animal reproductive toxicity studies recently completed with RDEA806 have demonstrated no effects on male or female fertility or on early embryonic development at all tested doses. These results are in contrast to the fetal malformations reported in other non-nucleoside reverse transcriptase inhibitor (NNRTI) animal reproductive toxicity studies.
In addition, the novel second-generation NNRTI, RDEA427, was selected as a development candidate for the potential treatment of the human-immunodeficiency virus (HIV), the causative agent of AIDS.
Barry Quart, president and CEO of Pharma division at Ardea, said: “The ability to use RDEA806 in women, without the risk of birth defects, is a major advantage over the current first-line NNRTI. Women make up 26% of HIV/AIDS diagnosed patients in the US, and an even larger percent of infected patients worldwide. These preclinical data for RDEA806 further strengthen its impressive product profile.”