Press Release: IND opens for anti-Staphylococcal drug XF-73 and NIAID-funded US clinical trial begins

Brighton, UK – Clinical stage pharmaceutical company Destiny Pharma
today made two important announcements about its lead drug for the prevention
of post-surgical Staphylococcal infections, XF-73. The drug has
progressed through the Food and Drug Administration (FDA) to an open
Investigational New Drug (IND) status and Phase I clinical evaluation
is being initiated in the US. The clinical trial is funded by the National
Institute of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH). This latest evaluation follows three successful
XF-73 clinical trials in the UK.

The clinical trial will study Staphylococcus aureus (SA) decolonisation
as well as safety and tolerability in more than fifty subjects who are
treated with XF-73 or placebo. The study will go beyond the UK trials
by more accurately simulating patient SA decolonisation, important in
mitigating the risk of subsequent SA infection.

Infection remains a worrying complication for hospital admissions.
The most common cause of infection is the bacteria Staphylococcus
aureus
(SA). Methicillin-Resistant Staphylococcus aureus
(MRSA) decolonisation is now practiced in many countries, but the continuing
problem of bacterial resistance prevents the protection being extended
to the larger number of patients who could benefit. There is global
need for drugs that can effectively prevent SA infections in patients
without succumbing to bacterial resistance. In the US alone it is estimated
drug-resistant forms of SA such as MRSA result in 19,000 deaths per
year (2). The annual cost of Staphylococcus aureus infection
in the US is put at $9.5 billion (3).

Studies to date have shown XF-73 is rapidly bactericidal and has unique
abilities to prevent bacterial resistance (1). Its creators at Destiny
Pharma believe XF-73 could be used to prevent potentially fatal SA infections,
an approach which is becoming compromised due to a limited number of
antibiotics and antibiotic-resistance.

NIAID’s funding is part of its commitment to explore innovative approaches
to the problem of antimicrobial resistance. The Institute uses its clinical
research infrastructure to support the evaluation of drugs that may
be able to address significant public health needs.

Dr Bill Love, CEO of Destiny Pharma commented: “We’re very
pleased to have the IND open for XF-73 which is a significant milestone
for the Company on the route to the global development of this important
new antibacterial drug. We could not have better partners in the form
of NIAID and look forward to the next stages of developing this drug
and enabling its use in hospitals.

XF-73 is a novel dicationic porphyrin with rapid bactericidal activity
against Gram-positive bacteria including Staphylococcus aureus (methicillin
sensitive and multi-drug resistant strains including MRSA).

References:
1. Farrell D, et al. Investigation of the Potential for Mutational Resistance
to XF-73, Retapamulin, Mupirocin, Fusidic Acid, Daptomycin, and Vancomycin
in Methicillin-Resistant Staphylococcus aureus Isolates during
a 55-Passage Study. Antimicrobial Agents and Chemotherapy (2011); 55:
1177-1181 No. 3
2. http://www.cdc.gov/mrsa/statistics/MRSA-Surveillance-Summary.html
3. Noskin GA, et al. The burden of Staphylococcus aureus on hospitals
in the United States: an analysis of the 2000 and 2001 Nationwide inpatient
sample database. Arch Intern Med (2005); 165: 1756-61

About Destiny Pharma:
Destiny Pharma, a clinical stage pharmaceutical company, was founded
in 1997. The Company focuses on the R&D of new antimicrobial drugs,
with an emphasis on novel mechanisms of action which seek to address
a top 3 global healthcare issue, namely, microbial drug resistance.
XF-73 is the Company’s lead drug which has completed Phase I clinical
development in the UK. Through its extensive business network and strategic
partnerships, Destiny Pharma intends to globally commercialise candidates
from the XF Drug platform which are differentiated by design from traditional
antibiotics.

About the NIH and NIAID:
NIH, the U.S. medical research agency, includes 27 Institutes and Centers
and is a component of the U.S. Department of Health and Human Services.
NIH is the primary federal agency conducting and supporting basic, clinical,
and translational medical research, and is investigating the causes,
treatments, and cures for both common and rare diseases. For more information
about NIH and its programs, visit www.nih.gov.

The National Institute of Allergy and Infectious Diseases (NIAID) conducts
and supports research-at NIH, within the U.S. and worldwide-to study
the causes of infections and immune-mediated diseases and to develop
better means of preventing, diagnosing and treating these illnesses.
News releases, fact sheets and other NIAID-related materials are available
on the NIAID website at www.niaid.nih.gov.

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 about NIAID, visit www.niaid.nih.gov

For further information about Destiny Pharma contact:
pressoffice@destinypharma.com

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