Pasadena-based Arrowhead Pharmaceuticals Inc. has focused on treating diseases through an RNA-based platform that acts to silence genes that cause the particular disease being targeted. The company has focused a lot of its attention on cardiovascular, metabolic and pulmonary diseases and conditions.
Arrowhead is now entering the obesity medicine market, where wildly popular next-generation drugs like Wegovy and Ozempic (both developed by Bagsvaerd, Denmark-based Novo Nordisk) are now frequently in short supply. The company is preparing to bring for clinical trials two drugs for the treatment of obesity and metabolic diseases.
“Following the approval and positive clinical impact of new agents for obesity over the last few years, new therapeutic strategies with novel mechanisms of action are emerging that may represent the future in successful treatment and management of patients with obesity and associated diseases,” James Hamilton, Arrowhead’s chief of discovery and translational medicine, said in the company’s Aug. 14 announcement.
According to announcement, the two drug candidates demonstrated the potential to reduce body weight and fat mass by appearing to preserve more lean muscle mass than other currently approved obesity therapies. Arrowhead has yet to give brand names to the drug candidates.
“Arrowhead has two promising new RNAi-based programs with the potential to address obesity in a new way,” said Christopher Anzalone, the company’s chief executive.
Anzalone added that both drugs have “good genetic validation,” and that the pathway used to signal the body to store fat is well understood.
The company plans to submit clinical trial applications with regulatory authorities – primarily the U.S. Food and Drug Administration – for both drug programs by the end of this year with the goal of initiating clinical studies in volunteers with obesity early next year. Anzalone said the company hopes to start data readouts from the clinical trial sometime next year.
Assuming these two drugs begin clinical trials next year as expected, they would join 14 other drugs Arrowhead already has in clinical development. Several of those drugs are in Phase 3 clinical trials – the final trial stage before the drugs are submitted to the FDA for approval.
The announcement of these two new drug candidates did halt a modest slide in Arrowhead stock from the upper $20 range to the lower $20 range; since then, the stock has generally stayed in that latter range.
