Destiny Pharma granted FDA designation for antibacterial drug

XF-73, a new drug being developed by biopharmaceutical company Destiny Pharma to prevent bacterial infections including the MRSA 'superbug', has been granted Qualified Infectious Disease Product (QIDP) designation by the US Food and Drug Administration (FDA).

XF-73 (Exeporfinium chloride) is a novel, synthetic drug with anti-bacterial activity against a broad range of bacteria. The drug is being developed against the Staphylococcus aureus bacteria, including the multi-antibiotic resistant strain, Methicillin-Resistant Staphylococcus aureus (MRSA).

Infection remains a major complication for hospital admissions, with these SA bacteria the most common cause. Infection prevention measures, including decolonisation of the bacteria ahead of surgery in at-risk patients are now practised in many countries, but the continuing problem of bacterial resistance prevents the procedure from being extended to the larger number of patients who could benefit. There is an urgent global need for drugs that can effectively prevent SA infections in patients without succumbing to bacterial resistance. In the US alone, it is estimated that drug-resistant forms of SA - such as MRSA - result in 19,000 deaths per year. The annual cost of SA infection in the US is put at $9.5 billion.

A recent report in medical journal The Lancet estimated that between 38-51% of bacteria that cause post-surgical infections are resistant to traditional antibiotics used, and that a 30% reduction in current antibiotic effectiveness could result in 120,000 additional post-surgical and chemotherapy-related infections in the US alone.

The FDA grants QIDP designations to drugs intended to treat serious or life-threatening infections, caused by "qualified pathogens". Under the GAIN (Generating Antibiotic Incentives Now) Act, XF-73's QIDP status confers FDA priority review, eligibility for fast-track status and an additional five-year extension of US patent exclusivity when approval is granted.

"The QIDP designation is an important milestone in the development of our lead product XF-73 which represents a new approach in hospital infection prevention for millions of surgical patients," said Dr Bill Love, CEO of Destiny Pharma. "Around the world, governments and global organisations are calling for new anti-bacterial drugs and are introducing incentives to reward companies for delivering these products. Tackling antibiotic resistance is on the G7 agenda and industry is starting to return to this space. XF-73 has a novel bacterial-killing action which offers the potential of a more comprehensive surgical infection prevention program."

Data from four Phase I/IIa studies in Europe has shown that XF-73 rapidly reduces the number of bacteria in the nose when applied as a nasal spray. Coupled with the unique property to prevent bacterial resistance demonstrated in laboratory tests, XF-73 promises to be able to prevent potentially fatal infections. In the US, a clinical trial of XF-73 is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and is expected to complete shortly.