ChemoCentryx has secured a credit facility of up to $100 million from Hercules Capital to support the upcoming costs of its new drug application (NDA) for avacopan, its investigational treatment for ANCA-associated vasculitis (AAV), and the therapy’s commercial launch, if approved.
The $100 million credit will be divided into three separate tranches over the next two years, the biopharmaceutical said.
The first tranche, of $40 million, will be available through December 2020, with $20 million accessible upon avacopan’s NDA submission to the U.S. Food and Drug Administration. The second funding slice, totaling $30 million, will be available until Dec. 2021 upon NDA approval. The remaining tranche, for $30 million, will be accessible through Dec. 2022, subject to certain conditions, according to ChemoCentryx.
“Through this non-dilutive credit mechanism, we have options to strengthen our robust balance sheet as we advance avacopan towards commercialization in ANCA vasculitis,” Thomas J. Schall, PhD, ChemoCentryx’s president and CEO, said in a press release.
ANCA-associated vasculitis is an autoimmune disease associated with the inflammation and destruction of small blood vessels. Most people with AAV develop kidney disease and are at risk of kidney failure.
Several studies have shown that the complement system — a set of more than 30 blood proteins that contribute to the body’s natural immune defenses — plays a major role in the development of AAV. There also appears to be an association between complement protein levels and AAV-associated kidney damage.
Avacopan (CCX168), an oral therapy developed by ChemoCentryx, works by specifically blocking C5a, one of the most potent pro-inflammatory proteins of the complement system.
In the ADVOCATE study, 331 people with AAV were randomly assigned to receive either avacopan or prednisone in combination with the standard-of-care for 52 weeks.
The trial met both of its primary goals: remission at week 26, and sustained remission at 52 weeks. The results were determined by changes in the Birmingham Vasculitis Activity Score (BVAS), compared from the study’s start to week 26 and 52. Avacopan also was well-tolerated, showing an acceptable safety profile.
Based on these positive findings, the company and its collaborator, Vifor Pharma, are planning to file a full marketing authorization seeking the approval of avacopan for the treatment of AAV both in the U.S. and in Europe.
ChemoCyntryx holds all U.S. rights to avacopan, while its…