Arrowhead Research Corp (NASDAQ:ARWR) has finally been given the go ahead sign to beggin its phase II B trials of ARC 520. The company will now be able to further its research on the Hepatitis B treatment courtesy of the FDA.
Despite the approval, the company still has to persuade other supervisory bodies before it can launch larger efforts. The ARC 520 is an RNA treatment that is aimed at fighting the Hepatitis B Infection Company has larger plans towards the rolling out of Heparc-2004. It is a placebo controlled experiment that will take in 12 patients and carry out experiments and tests. The aim is to test how responsive the ARC-520 drug will be in reducing the Hepatitis B levels
The test patients are expected to receive 1milligram per kilogram of the ARC-520 or the Placebo, which will be administered once per four weeks. The trial period will be tracked over 147 days.
Despite the FDA’s approval, the drug agency will still continue to uphold its limit on Arrowhead’s administration of the drug. The company’s initial plan was to run the phase ii study where two patient study groups were supposed to get 2 and 4 milligrams per KG. The administration was supposed to be parallel. However, the FDA expects more trials and more results before allowing the biotech to proceed.
In the meantime, Arrowhead will continue to work on the Heparc-2004 drug and rolling it out as soon as possible. The increment has cheered up investors with the 16% rise in share value.
The ARC-520 is the top priority of the biotech company in its RNA interference treatments.
The treatment portfolio involves research on rare disease treatment as well as preclinical assets for liver treatments.
The company made news a month ago when it made a $35 million deal to take over the assets discarded by Novartis AG (ADR) (NYSE:NVS). The agreementreplacedthat of Roche which was made in 2011.