SkinBioTherapeutics plc (LON:SBTX), a life science company focused on skin health, has today provided the following update:
The design of the human study planned for Q3 2018 has now been finalised. This will be conducted independently by Alba Science Limited, a clinical research organisation based in Edinburgh, which has many years of experience in the field of cosmetic testing.
The six week study will be conducted on 120 female volunteers with self-assessed ‘dry skin’. Initially the study was planned to be undertaken with 60 participants but this has now been doubled to make this one of the most substantial sized studies in this field.
The following measurements will be taken over the course of the study:
– visual assessment of skin dryness
– skin hydration (corneometry)
– skin barrier function (transepidermal water loss – TEWL)
Skin swab samples will also be taken at the beginning and end of the study to examine the effects of the technology on the skin microbiome.
The cream formulation of SkinBiotix® will be applied three times daily to delineated areas of the legs and measurements repeated after two and four weeks. Analysis of the data will take a further two weeks. Consequently, the entire study is likely to take around eight weeks.
The anticipated outcomes are that the hydration of the skin will be improved by the SkinBiotix® cream; the barrier function will be stronger (shown by a decrease in water loss across the skin barrier) and that the technology is safe for the skin microbiome. These are all characteristics of interest to partners for the development and commercialisation of a successful cosmetic product.
The Company has made further progress with its lysate manufacturing process. A new method of manufacture that is scalable has been successfully trialled and results indicate no detrimental impact upon the active properties of the SkinBiotix® technology.
Further work is required to optimise the process to achieve manufacture on a commercial scale but the progress to date is encouraging.
The Company’s first patent, covering the use of specific probiotic bacteria and lysates in the treatment of skin in health and disease, which was granted in Australia in November 2017, has now been granted in New Zealand and Russia. While not deemed to be key jurisdictions, the Company is pleased to see progress in its patent portfolio. Active prosecution of the patent application in other locations including Europe, USA and China is ongoing.
Dr Cath O’Neill, CEO of SkinBioTherapeutics Plc, commented: “We are really pleased with the progress we have made across design of the human efficacy study and with the upscaling of the lysate manufacturing.
“We are determined to make the study as impactful as possible, which is why we have doubled its size. The cost impact is marginal, but the increase in the strength of the potential data and hence, to future partnering discussions, could be significant. Scaling up the manufacturing process is a key step in our development, and we are also moving this forward very well.”