The approval of Human Genome Sciences/GlaxoSmithKline’s Benlysta last year ended a drought of new drug approvals for the autoimmune disease lupus that had lasted more than half a century.
A lengthy pipeline of drugs is hoping to follow suit, including a preclinical biologic compound from a University of Washington spinoff that is hoping to progress to clinical trials next year.
Resolve Therapeutics has just completed a $5.8 million series B, following up a $2 million series A done in 2011. The cash came from previous investors New Science Ventures and Easton Capital, and new investor WRF Capital, the venture investment arm of the Washington Research Foundation.
With the new money, Resolve will be able to advance its investigational lupus compound into clinical trials, which are expected to start in mid-2013, CEO James Posada said in a statement. The compound is currently in IND-enabling studies.
Spun off with research from UW in early 2010, Resolve has formulated two families of proteins that bind to and degrade immune complexes circulating in lupus patients’ blood. Its lead compound, the biologic therapy RSLV-132, is being developed to inhibit the production of interferon-alpha, thought to be a key trigger in the inflammation that occurs in lupus patients.
Lupus can cause symptoms like extreme fatigue, joint pain, headaches and shortness of breath. Current treatment regimens include anti-inflammatory medications, corticosteroids, anticoagulants and immunosuppressive medications, which don’t modify the disease and often have serious side effects.
The virtual startup’s business model hinges on a licensing agreement with a pharmaceutical partner, which doesn’t seem like a long shot given Big Pharma’s interest in lupus over recent years. Market research firm GlobalData estimated the global market for lupus therapeutics would grow nearly 25 percent annually through 2018, bolstered by the approval of Benlysta and the anticipated approval of biologic drugs from Eli Lilly, Immunomedics and Merck KGaA. Earlier-stage anti-interferon alpha therapies are under development by Genentech, Medimmune, Argos Therapeutics and GlaxoSmithKline.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“The leading pharmaceutical companies are excited by (the technology) as well, which portends a bright future for Resolve,” Posada said.
