For all investors, Acne trial was a disappointment with vehicle showing better efficacy than active agent in US arm. Naturally one may suspect if the same issue with vehicle would happen with the Dermatitis Study despite the reassurance that the manufacturing of vehicle and active agent has been made more consistent since the Acne trial. It is important to note another major difference. This was the first time BTX 1503 was compared with a vehicle. I believe that BTX 1204 phase 2 will have different outcome as it has already shown better efficacy vs vehicle.
Phase 1b trial of BTX 1204 used comparison of active agent with a vehicle and it was twice as effective as the vehicle. This was not the case with Phase1b trial of BTX 1503 where only active agent was used. This gives us the reassurance that BTX 1204 is not only effective but the separation from vehicle can be clearly established.
Phase 1 b data BTX 1204
"Study data indicated BTX 1204 was twice as effective over the vehicle with substantial
improvement in the key signs of atopic dermatitis
• BTX 1204’s efficacy still increasing at the 4-week timepoint, suggesting a longer treatment
period enables BTX 1204 to potentially exceed industry performance
• Achieved clear separation from vehicle, with BTX 1204 showing superiority over vehicle at
an early stage of the treatment period
• BTX 1204 demonstrated an excellent safety profile allowing for extended dosing, which
remains a key challenge for other available therapies"
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