XF-73 is the lead drug in Destiny Pharma's pipeline, currently in clinical development for the prevention of post-surgical Staphylococcal infection, the world's number one casue of hospital bacterial infections.

Infection control protocols now emphasise not only the need to screen patients entering hospital, but to effectively decolonise all body carriage of Staphylococcus aureus, including nasal carriage (the major ecological niche for Staphylococci)

"Patients receiving prophylaxis for an operative procedure and in an outbreak situation under the advice of the infection control team should undergo nasal decolonization." Coia JE, JHI 2006

Acting as a reservoir, nasal carriage of Staphylococcus aureus poses a significant health risk. Unfortunately, it is becoming resistant to existing topical antibiotics used in nasal decolonisation, severely compromising their effectiveness and leaving thousands of patients open to the risk of infection, especially MRSA.

Staphylococcus aureus (SA) is the most common cause of bacterial infections aquired in Western hospitals across the world (Emori et al 1993) and at least 80% of such infections are from the patients' own bacteria (Weinstein 1959; Von Eiff et al 2001). SA can colonise several body sites, however, the anterior nares (nostrils) have been identified as the most frequent site of carriage (Williams 1963) with 25 to 30% of the population being so colonised at any given time. Such patients are at a higher risk of staphylococcal infections after invasive medical or surgical procedures than non-carriers, having been estimated to be 2 to 9 times more likely to succumb to surgical-site/ intravenous catheter infections (Wertheim et al 2004; Perl et al 1998; Wenzel et al 1995). Such infections are associated with substantial morbidity and mortality, having a significant impact on health-care costs. In 2003 it was estimated that 0.8% of all hospitalised patients in the US suffered from SA infections, equating to nearly 300,000 patients (Noskin et al 2005), at an estimated excess cost of $9.5 billion. In Europe and the rest of the world there is no reason to consider a different situation with an annual estimate of 400,000 patients affected in Europe and 125,000 in Japan. SA nasal carriage has been identified as a risk factor for the development of infections in orthopedic, cardio-thoracic and general surgery as summarised in a review by Wertheim (Wertheim et al 2005).

The clinical development of XF-73 is targeted at intranasal administration to reduce the risks posed by staphylococcal carriage (MSSA & MRSA)

• Three successful Phase 1 clinical trials have been conducted in the UK involving >90 healthy volunteers to establish safety and tolerability of intranasal XF-73 in a gel formulation
• The first XF-73 clinical data was presented at the Inter-sciences Congress on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston, US, in October 2010
• The clinical data demonstrated that at the XF-73 dosing regimen employed there were no safety or tolerability issues
• These studies also evaluated anti-staphylococcal activity by including SA positive healthy volunteers. The results achieved have been encouraging with evidence of anti-staphylococcal activity of XF-73

The clinical adoption and economic value of screening and decolonisation of all Staphylococcus aureus (SA), i.e. both MRSA and MSSA continues to yield positive results as demonstrated in three recent trials/studies reported by other investigators:

1. Bode et al 2010, Erasmus University Medical Centre, NL; Preventing surgical site infections in nasal carriers of Staphylococcus aureus. New Eng J Med 362;9-17; in which Bode concludes that the number of surgical site Staphylococcus aureus (SA) infections acquired in the hospital can be reduced by rapid screening and decolonising of nasal carriers of SA on admission.

2. Kim et al 2010, New England Baptist Hospital, Boston, US; Institutional pre-screening for detection and eradication of MRSA in patients undergoing orthopaedic surgery. J Bone Joint Surg Am (2010) 92: 1-7. In which Kim concludes that implementation of an institution-wide pre-screening program for the identification and eradication of MRSA and MSSA carrier status among patients undergoing elective orthopaedic surgery is feasible and can lead to significant reductions in post-operative rates of surgical site infection.

3. Scott et al 2011, University College London, UK; Rapid molecular screening for MSSA carriage: An economic evaluation. Journal of Infection Prevention, (2011), 12;3; 119-125. In which Scott concludes that adopting rapid screening and treating MSSA nasal carriers should be clinically and financially advantageous, compared to current strategies of not screening, even under conservative assumptions for costs and probabilities of managing infections

For further information please contact us
at busdev@destinypharma.com.