Building on its earlier success with a gene-silencing drug for patients with chronic hepatitis B infection, Pasadena-based Arrowhead Pharmaceuticals Inc. has filed an application to begin a Phase 1 clinical trial of a new possible treatment for hypertriglyceridemia, a condition which denotes high blood levels of triglycerides.
The new investigational medicine, ARO-APOC3, is another RNAi (ribonucleic acid interference)-based drug, the fifth of Arrowheads product candidates that leverage the Targeted RNAi Molecule, or TRiM, platform to enter clinical studies.
An Arrowhead Pharmaceuticals statement Monday said the application for approval of the clinical trial is being submitted to a local ethics committee and to the New Zealand Medicines and Medical Devices Safety Authority.
The statement added the new drug targets Apolipoprotein C-III (apoC-III) and is being developed for the treatment of hypertriglyceridemia, a risk factor for coronary artery disease.
Currently, weight loss and dietary modification are effective first-line lifestyle modification treatments for hypertriglyceridemia.
Addressing hypertriglyceridemia through reduction of liver-produced apoC-III offers multiple potential development opportunities, including both orphan indications, such as FCS, and large market indications, Dr. Chris Anzalone, Arrowhead President and CEO, said. In AROAPOC31001, our first-in-human study, we intend to evaluate ARO-APOC3 in healthy volunteers and various patient populations with elevated triglycerides, which will help inform our strategy around the ideal development and regulatory paths to pursue.
Earlier this year, Arrowhead Pharmaceuticals entered into a license and collaboration agreement with Janssen Pharmaceuticals, Inc., a Johnson & Johnson subsidiary, to develop and commercialize ARO-HBV, its gene-silencing drug for chronic hepatitis B infection.
Arrowhead also signed a research collaboration and option agreement with Janssen to potentially develop up to three additional RNAi therapeutics against new targets that Janssen will select.