Destiny Pharma Announces Qualified Infectious Disease Product Designation Granted by US FDA for Novel Antibacterial Product
BRIGHTON, England, November 11, 2015 /PRNewswire/ --
In Development for Prevention of Post-Surgical Staphyloccocal Infections
Destiny Pharma Ltd, a leading, clinical stage biopharmaceutical company focused on developing and commercialising antibacterial drug products, today announced that the US Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to Destiny Pharma's lead drug product candidate, XF-73 (Exeporfinium chloride). This is a novel, synthetic drug with anti-bacterial activity against a broad range of bacteria. The drug is being developed against the bacteria, Staphylococcus aureus, including the multi-antibiotic resistant strain, Methicillin-Resistant Staphylococcus aureus (MRSA).
The QIDP designation for XF-73 is for the prevention of post-surgical Staphylococcal infections and there are tens of millions of patients entering hospitals each year who are at significant risk of contracting a post-surgical infection because they 'carry' this bacteria. Under the GAIN (Generating Antibiotic Incentives Now) Act, 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 FDA grants QIDP designations to drugs intended to treat serious or life-threatening infections, caused by "qualified pathogens". These pathogens include the hospital Superbug, MRSA, one of the leading causes of post-surgical infections.
Data from four Phase I/IIa studies in Europe has shown that XF-73 is rapidly bactericidal i.e. reducing the number of bacteria in the nose quickly. Coupled with the unique property to prevent bacterial resistance demonstrated in laboratory tests[1], XF-73 promises to be able to prevent potentially fatal Staphylococcus aureus infections. An approach which is becoming compromised due to a limited number of antibiotics and antibiotic resistance. In the USA, 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.
Dr Bill Love, CEO of Destiny Pharma, commented: "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. 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."
About Destiny Pharma:
Destiny Pharma, a clinical stage biopharmaceutical company, was founded in 1997. The Company focuses on the R&D of new antimicrobial drugs, with an emphasis on novel mechanisms of action that seek to address the global healthcare issue, namely, Antibiotic Resistance. XF-73 is the Company's lead drug which has completed 4 Phase I/IIa clinical studies in the UK/Europe. Through its extensive business network and strategic partnerships, Destiny Pharma intends to globally commercialise candidates from the XF Drug platform based on dicationic porphyrins which are differentiated from traditional antibiotics structurally. XF drug candidates are able to kill static and growing bacterial cultures, as well as bacteria with biofilm and may thus see limited resistance development. Non-growing cultures often become resistant to traditional antibiotics that rely on the bacteria actively growing to kill them. Additional information on Destiny Pharma is available at http://www.destinypharma.com
About infections and hospital admissions:
Infection remains a major complication for hospital admissions. The most common cause of infection is the bacteria Staphylococcus aureus (SA), including the antibiotic resistant form, MRSA. Infection prevention measures including decolonisation of SA/MRSA ahead of surgery in at-risk patients are now practised in many countries, but the continuing problem of bacterial resistance prevents the procedure 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 USA alone it is estimated drug-resistant forms of SA such as MRSA result in 19,000 deaths per year. The annual cost of Staphylococcus aureus infection in the US is put at $9.5 billion.
A report in The Lancet 15th October 2015[2], estimates 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 USA alone.
References:
1. David Farrell et al., "Investigation of the potential for mutational resistance to XF-73, Retapamulin, Mupirocin, Daptomycin, Fusidic acid & Vancomycin in MRSA isolates during a 55 passage study." Antimicrob. Agents & Chemo., (2011), p1177
2. Aude Teillant et al., "Potential burden of antibiotic resistance on surgery and cancer chemotherapy antibiotic prophylaxis in the USA: a literature review and modelling study.", The Lancet Online, 15th Oct 2015. http://dx.doi.org/10.1016/S1473-3099(15)00270-4
Forward Looking Statement:
This press release contains forward-looking statements that are subject to risks and uncertainties and includes statements that are not historical facts. Actual results could differ significantly from results discussed. Destiny Pharma disclaims any intent or obligation to update forward-looking statements except as required by law.
For further information please contact:
Hume Brophy
Mary Clark, Eva Haas, Hollie Vile
Tel: +44-20-3440-5813
Email: [email protected]
SOURCE Destiny Pharma
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