Ann: Phase 2a Study Shows BTX 1801 Eradicates S. Aureus, page-861

When the 1801 results were announced I was pleased that the primary endpoints had been achieved but was left with a few questions. I popped off an email to Botanix and this morning was able to get some answers. They could not have been any more open and forth coming, very appreciative. Thought I would share some insights:

- All 66 participants completed the trial. The participants were tested 3 times prior to the trial to determine if they had Staph Aureus. If they did not have a staph infection on the third test their data was not included and hence the percentages (A post yesterday clarified the calculations).

- There was no data collected at the end of day 5 as the trial was set up around the protocols of trials completed for other nasal decolonization products.

- 2 participants had MRSA, too few to be considered statistically significant. 1 in the vehicle group and 1 in the ointment group. The MRSA in the vehicle group was not eliminated, while the MRSA in the ointment group was successfully eliminated. Botanix had hoped there would be more MRSA cases.

- Side effects were really very mild, a little crustiness in some cases.

- The ASX no longer allow pharmaceutical companies to present comparisons with other company’s trials in announcements.

- The level of nasal staph was coded as eliminated, light, moderate or high. Data about staph levels in participants who were not classified as eliminated is still to come through.

- Participants who were recolognised by staph had there staph treated again and the staph was, in all cases, still susceptible suggesting no resistance development.

- In terms of recolognisation, staph is carried on many parts of the body and persistent carriers recolognize a lot. Other nasal decolonization studies gave participants full body chlorhexadine washes prior to the trial, something that was not done in Botanix’s trial.

- More data about the 1801 trial is still to come in.

-Matt Callaghan will be presenting remotely at a conference next week and hopefully will provide more data about the trial.

It is clear to me that Botanix genuinely believe the data is very good and compares well to competitors in the staph decolonization space, dialysis is one area they think this has some real potential.

My doubts about the results, based on some basic Google searches of other trials, were completely allayed. IMO Botanix is on to something and I’m not selling any time soon. Look forward to Matt’s presentation next week.