Arrevus Receives Support from FDA in Developing Cystic Fibrosis Drug

Raleigh-based biotechnology company Arrevus has received an important Food and Drug Administration designation to support development of its drug to address the worsening symptoms of cystic fibrosis.

The FDA has granted Qualified Infectious Disease Product (QIDP) status to ARV-1801, Arrevus’ investigational sodium fusidate tablet to treat cystic fibrosis (CF) pulmonary exacerbations. These episodes, which occur often in patients with CF, decrease lung function and increase the risk of death over time. There currently are no approved treatments. 

QIDP was created by Congress to spur development of new antibiotics to treat serious or life-threating infections that attack at least two million people in the United States each year. The designation can result in an extended period of market exclusivity for medicines.

ARV-1801 is the only member of the fusidane class of antibiotics that, while it is available globally, is considered a new molecular entity in the United States, according to Arrevus. The company said fusidic acid – the active component of the drug – has been in clinical use outside the U.S. for more than 50 years and has an excellent safety profile. It already is included in multiple approved indications for CF.

Arrevus plans to conduct a phase 2 clinical study to examine the effectiveness of ARV-1801 as a treatment for pulmonary exacerbations, the driving force behind lung function decline in cystic fibrosis patients. The progressive disease affects approximately 30,000 people in the United States, and they normally live only to their mid-to-late 30s.

“We know that ARV-1801 is one of the very few oral antibiotics that has increased potency in low pH environments and also has anti-inflammatory activity, both of which are critical to any antibiotic targeting the lungs of CF patients experiencing exacerbation,” said Carl N. Kraus, M.D., founder and CEO of Arrevus.

The North Carolina Biotechnology Center has supported the company’s development of ARV-1801 with a $250,000 Small Business Research Loan it awarded in 2019.

Arrevus, founded in 2015, focuses on developing novel drugs that address unmet medical needs in areas with high treatment failure rates, few therapeutic options and serious outcomes.