ChemoCentryx Secures $100M Credit to Support Avacopan’s Approval Applications, Potential Commercial Launch

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.

After avacopan’s promising results in two Phase 2 trials — CLEAR (NCT01363388) and CLASSIC (NCT02222155) — ChemoCentryx launched the ADVOCATE Phase 3 trial (NCT02994927).

That pivotal study showed that the therapy effectively improved remission rates, kidney function, and quality of life in AAV patients, compared with the standard therapy prednisone.

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 partner, Vifor Pharma, will have marketing rights in the rest of the world, should avacopan be approved.

“Given the positive clinical evidence from avacopan, Hercules is pleased to further expand its financing partnership with ChemoCentryx as it continues to advance avacopan through regulatory submissions and commercialization subsequent to approval, and to develop additional product candidates,” said Himani Bhalla, Hercules’s life sciences fund group principal.

The funding will support avacopan’s movement through the regulatory process, Schall said.

“With the secured capital on hand and anticipated milestone payments, we are financially well-positioned to successfully commercialize avacopan in this important and underserved disease,” he said.

Hercules Capital is a leader finance company focused on providing loans to companies in life sciences and technology-related markets.

Avacopan has received orphan drug designation from the FDA as well as priority medicines, or PRIME, designation from the European Medicines Agency (EMA).

These designations are intended to speed up avacopan’s development and review, as well as to provide regulatory support, financial benefits, and marketing exclusivity for a period of time upon approval. The exclusivity period is seven years in the U.S. and 10 in Europe.