FDA Grants Priority Review to ARV-1801, Potential Antibiotic for Pulmonary Flares in CF

FDA Grants Priority Review to ARV-1801, Potential Antibiotic for Pulmonary Flares in CF
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Arrevus announced that the U.S. Food and Drug Administration (FDA) has given a form of priority review to ARV-1801 (sodium fusidate tablets), a potential oral treatment of pulmonary exacerbations in people with cystic fibrosis (CF).

A clinical trial in patients is in planning stages, the company added in a press release.

This designation came in the form of a Qualified Infectious Disease Product (QIDP) award, and is intended to provide incentives to speed the development of “antibacterial and antifungal drug products” for serious or life-threatening infections,  and their regulatory review for possible approval.

The accumulation of thick mucus in the lungs is a CF hallmark, and can create a favorable environment for the growth of bacteria. Lung bacterial infections often lead to episodes of pulmonary exacerbations, or flares, during which there is an acute worsening of lung function.

Frequent exacerbations can cause a permanent decline in lung function over time.

Sodium fusidate is one of the most potent antibiotics against the bacteria Staphylococcus aureus, a cause of about 70% of  lung infections in CF patients. The antibiotic is also effective against methicillin-resistant Staphylococcus aureus (MRSA), a particularly difficult to treat infection.

The compound also has anti-inflammatory and mucolytic (mucus clearing) properties.

“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” Carl N. Kraus, MD, founder and CEO of Arrevus, said in the release.

Currently, no specific therapy in the U.S. is indicated to treat pulmonary exacerbations, the company reported.

Arrevus is planning to open a Phase 2 clinical trial of ARV-1801 in treating pulmonary flares in people with CF, having secured funding for a development program.

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

Sodium fusidate is considered an investigative therapy in the U.S., but is part of  treatment guidelines for bacterial decolonization in CF patients in Australia and the U.K.

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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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