The US Food and Drug Administration (FDA) granted orphan drug status to the experimental P113D peptide for the treatment of cystic fibrosis-related infections, biotechnology firm Demegen Inc. said on Tuesday.
P113D is a peptide derived from histatins, which are found in human saliva. According to Demegen, P113D has been shown in pre-clinical testing to act against bacterial isolates resistant to traditional antibiotics. However, the company noted that a number of preclinical toxicology evaluations still must be completed before human trials can begin.
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