Raleigh biotech startup Arrevus gets FDA support for its drug treating cystic fibrosis patients

RALEIGH — Cystic fibrosis (CF) is a heredity disease with no cure. However, Raleigh biotech startup Arrevus believes it owns a drug that could potentially extend the lifespans of those living with the disease — and it’s just got one step closer to making that a reality.

Arrevus today announced the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation for ARV-1801 (sodium fusidate tablet) for the treatment of pulmonary exacerbations in CF patients.

These episodes of “acute worsening of pulmonary status” occur frequently in patients with cystic fibrosis, and result in a sequential and permanent decline in lung function.

“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 an exacerbation,” said Dr. Carl N. Kraus, founder and CEO of Arrevus, in a statement.

ARV-1801 (sodium fusidate) is the only member of the fusidane class of antibiotics that is available globally and is considered a New Molecular Entity in the United States.

In February 2019, Arrevus purchased the ARV-1801 (sodium fusidate) program from Melinta Therapeutics.

Arrevus is planning to initiate a phase 2 study to examine ARV-1801 in the treatment of pulmonary exacerbations in patients with cystic fibrosis. Sodium fusidate is included in multiple treatment guidelines outside of the U.S. for bacterial decolonization in cystic fibrosis patients.

Dr. Donald VanDevanter, adjunct professor at Case Western Reserve University School of Medicine, a member of the Cystic Fibrosis Foundation’s STOP (Standardized Treatment of Pulmonary Exacerbations) initiative, and an advisor to Arrevus, said the proposed superiority design to evaluate ARV-1801 for PEx treatment is indicative of a strong commitment to improve outcomes for people with CF and their families,

“I’m excited to support their efforts,” he said.

In 2015, Kraus founded Arrevus after holding scientific and management roles in the pharmaceutical industry, including i3Research, a subsidiary of United Health Group, where he served as senior director of infectious diseases, over the past decade.

Kraus also worked at PRA International, where he was the global scientific head for infectious diseases. He has most recently served for three years as the chief medical officer for Nanotherapeutics, a biodefense-oriented biotechnology company.

The project is sponsored by the National Institutes of Health, Department of Health and Human Services.

To date, the startup has raised around $4.5 million in funding.