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Arrowhead discontinues multiple drug candidates for liver disease
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Arrowhead Pharmaceuticals announced it has discontinued development of three drugs currently being investigated in clinical trials for the treatment of various forms of liver disease administered via the company’s EX-1 delivery vehicle: ARC-520, ARC-521 and ARC-AAT. All patient recruitment for clinical trials have been halted and dosing discontinued.
Arrowhead said in a press release that while the drug candidates showed favorable tolerability in human clinical trials, the company will focus its development resources entirely on its subcutaneous and extra-hepatic delivery systems.
ARC-520 and ARC-521 (Arrowhead) were investigational drugs for hepatitis B virus infection. Recently, the clinical trial of ARC-520, Heparc-4000, was placed on clinical hold by the FDA due to deaths in an ongoing primate toxicology study that used EX1, the company’s liver-targeted, intravenously administered delivery vehicle, that was also being used in Heparc-4000.
Arrowhead announced in September an initiation of a phase 2 trial with ARC-AAT (Arrowhead), an RNA interference-based drug for the treatment of alpha-1 antitrypsin deficiency (AATD), a rare genetic disorder associated with liver disease in children and adults and pulmonary disease. The primary objective of the study was to measure the safety, endurance and effect of multiple, increased doses of ARC-AAT on levels of circulating and intrahepatic alpha-1 antitrypsin. The FDA granted Arrowhead orphan drug designation for ARC-AAT in June 2015.
The company said in the release that they were in support of advancing the programs due to its favorability in patients. So far, EX1-containing drugs have been administered over 800 times in
more than 300 patients and has been generally well tolerated; only 6% of infusions observed among patients were associated with infusion reactions. The company further stated that across the ARC-520, ARC-521, and ARC-AAT clinical programs, laboratory values were not deemed indicative of drug-induced organ toxicity.
The company said it will also focus on its partnership with Amgen and potential partnership for its other delivery systems in the future.
“Arrowhead remains committed to finding therapeutic options for patients with chronic hepatitis B infection and alpha-1 antitrypsin deficiency. The company intends to advance to the clinic two previously unannounced HBV and AATD programs using our subQ platform,” the company said in the release.