Nucleonics, Inc. has announced that it has received clearance from the US Food and Drug Administration for its Investigational New Drug (IND) application to begin a Phase 1 human safety study of Nucleonics' investigational eiRNA therapy for the treatment of chronic hepatitis B (HBV) infection. This clearance paves the way for the company to begin treating patients in June.
A total of 15 patients will be enrolled in the study, which will be conducted in the United States and Europe.
"We are very pleased to be able to move forward with this human safety study, which will be the first systemic delivery of an RNAi therapeutic to patients," said Robert Towarnicki, Nucleonics, Inc. president and chief executive officer.
"Our approach, which simultaneously targets four different regions of the HBV genome, offers the opportunity to destroy all of the different RNA molecules produced by HBV within an infected cell through RNA interference. Therefore, if successful, it could offer a significantly more potent antiviral therapy than has ever before been achieved.” Towarnicki added