Ann: Phase 2a Study Shows BTX 1801 Eradicates S. Aureus, page-940

A nasal decolonization phase 1 study that was published last year provides more confidence that BOT is on to something good IMO. Below are some extracts of interest:


There are few antibiotics specifically approved for intranasal use for S. aureus decolonisation, with mupirocin being the only topical preparation approved in the USA for eradication of MRSA carriage. As is the case with other antibiotics, widespread use of mupirocin has been reported to be associated with the emergence of mupirocin-resistant MRSA strains [12–16]. Therefore, there is a clinical need for alternative therapies to mupirocin for use in nasal decolonisation.XF-73 is a novel porphyrinic antibacterial drug that was developed for the treatment or eradication of S. aureus carriage.

Each study agent formulation (XF- 73 or placebo) was administered daily for 5 days (three times on Day1andtwicedailyonDays2to5).FromDay1toDay5,all subjects underwent body and face (avoiding the eyes, ears, mouth and nostrils) wash with the topical antiseptic chlorhexidine gluconate to prevent nasal contamination from other skin reservoirs.

As previously discussed, mupirocin is currently the only agent approved by the US Food and Drug Administration (FDA) for MRSA nasal decolonisation, and whilst its pre-operative use has shown considerable success in reducing MRSA colonisation in select patient populations [9–11], the durability of its effects and the emergence of drug-resistant strains continue to potentially limitits effectiveness [12–16]. Another concern with mupirocin is that it is slow to reach its full effect, generally requiring a 5-day, twice- daily application. Patient compliance with this self-application protocol is a common challenge. Furthermore, despite correct application and a full course of treatment, eradication of the S. aureus nasal carrier state and the durability of decolonisation has been shown to vary widely, ranging from no appreciable change to reducing colonisation by up to 59%.

Positive response to treatment was defined as reaching an absence of SA colonisation

I couldn’t get the result table to paste in a legible manner, however they key results of interest were:

Absence of SA was most successful in the 2% gel 0.5mg\g group. At day 6 - 63.6% then at day 14 - 54.5% (just remember the group were all washed with antiseptic days 1 to 5.

The study was considered successful and warranting further Phase 2 investigation.