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FDA Pauses Testing Of Arrowhead’s (ARWR) Hepatitis B Drug
Arrowhead shares tanked 22% during Monday’s trading session on the announcement that the FDA had temporarily restricted further clinical testing on the company’s hepatitis-B treatment drug
ARWR
By: HANNAH ISHMAEL
Published: Jan 13, 2015 at 4:44 pm EST
Arrowhead Research Corp (NASDAQ:ARWR) saw its shares tank 22% during Monday’s trading session on the announcement that the US Food and Drug Administration (FDA) had restricted further clinical testing on the company’s hepatitis-B drug ARC-520, and announced a partial hold. The FDA said in a preliminary notification that Arrowhead was allowed to begin Phase IIb testing on the drug; however, the company would need to make a few amendments to its clinical trials in order to have the partial hold removed.
Hepatitis B is a contagious disease, and is transmitted via infected blood. Around two billion people around the world are infected by this disease. Symptoms include jaundice, debility, and fever. Around 90% of infected adults recover by developing antibodies against the disease. However, children are mostly unable to develop antibodies, which develops further complications. Currently, vaccinations are used for prevention against the disease.
Arrowhead Research Corp. is a biopharmaceutical firm involved in the development of targeted RNA interference (RNAi) drugs. RNAi is a biological process that targets those genes in the human body which cause Hepatitis B. ARC-520 is expected to be Arrowhead’s first product in the market for the treatment of this contagious disease. It is under investigation for achieving a functional cure, which is defined as an "immune clearant state characterised by hepatitis B s-antigen negative serum with or without sero-conversion," in patients chronically infected with hepatitis B virus.
The company disclosed results for Phase IIa trials in October. The efficacy profile demonstrated that the drug did not live up to the expectations of investors.
The company initially suggested that patients be given multiple doses during Phase IIb trials, with a recommended dosage of two milligrams of the medication for every four kilograms of the drug. However, the FDA insisted that Arrowhead restart the trials with one milligram of medication for one kilogram of the drug.
Furthermore, the FDA also demanded that the results of the Phase IIa trial, in which patients were administered between 1-4 milligrams of the drug per kilogram, be shared. Arrowhead responded by commenting that the study is still undergoing in accordance with the initial plan, and there have been no issues of toxicity among the participating patients.
The drug makes use of a nano-polymer which has been designed specifically to treat the RNA. This new treatment enables the RNA to block the protein, which prevents the immune system’s identification of the hepatitis B virus. However, a dose of one milligram per kilogram reduces the build-up of the protein by only 9%. Arrowhead decided to test up to four milligram per kilogram to find out whether a better response was achievable or not.
CEO of Arrowhead, Christopher Anzalone added that the company would prepare for the Phase IIb trials next month, particularly stressing that Arrowhead would collaborate with the FDA throughout the trials. He also expressed the firm’s plan to register with Asian and European regulators to gain approval for initiating Phase IIb trials.
Gilead Sciences Inc. (NASDAQ:GILD) was interested in acquiring Arrowhead recently to expand its reach to other diseases apart from Hepatitis C. Since Arrowhead already had a drug for Hepatitis B in its pipeline, this move seemed fairly reasonable. The company might still be acquired by Gilead Sciences, and this speculation has led its shares to gain 66% in the last 30 trading days. |
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