Commencement of final phase of human studies
Manchester, UK – 20 November 2018 – SkinBioTherapeutics plc (AIM: SBTX – “SkinBioTherapeutics” or the “Company”), a life science company focused on skin health, announces the commencement of the third and final phases of its human study and provides a summary of key scientific and commercial milestones achieved so far in 2018.
Commencement of final phase of human studies
The final phase of the study seeks to ensure that the original SkinBiotix® technology retains the same beneficial property to improve skin barrier health when in a cream formulation. The Company is pleased to announce that the first of its 120 volunteers commenced testing last week. Provisional results for some of the volunteers are expected to be available for analysis at the end of December with the full read out on all 120 volunteers expected during Q1 2019.
The results of this final phase will complete the data pack to share with potential global partners interested in commercialising the SkinBiotix® technology in the cosmetic skin care market.
Key milestones achieved during 2018
During the course of 2018 the Company has achieved a number of important product development milestones which have reduced investor risk and reinforced the Board’s confidence in the potential of SkinBiotix® to deliver a wide range of cosmetic and dermatological applications. These applications are designed to address unmet needs in the large Cosmetic Skin Care (forecast to reach $180bn by 2024) and Dermatology (forecast to reach $14.2bn by 2021) markets.
Manufacturing scale-up and freeze drying of SkinBiotix® technology
Having previously only manufactured the SkinBiotix® technology on a laboratory scale and in a liquid format, the ability to scale up manufacture was identified as a significant development risk in the Company’s admission document. In the last 12 months, the Company, working with a third party, has successfully manufactured the SkinBiotix® technology to the scale required for commercial production and to meet the needs of potential global partners.
In addition to successfully scaling up manufacture, the Company has developed a freeze dried format for its SkinBiotix® technology. The ability to freeze dry a material is a critical step in developing a successful commercial product as it extends product shelf life, enabling storage and global distribution.
Successful safety and irritancy studies of cosmetic cream formulation (phase 1 and 2)
The SkinBiotix® technology had previously only been tested in laboratory and ex vivo skin studies as a raw ingredient. In order to test safety, irritancy, and effectiveness in human studies the Company needed to develop a cosmetic formulation which can be applied to human skin.
As part of its cosmetic product development, the Company successfully developed a cream formulation which passed stability and effectiveness studies in skin models (RNS: April 17th 2018) allowing it to be submitted for humans studies in September 2018.
The Company reported that in studies of 61 healthy subjects, no significant safety or irritancy effects were observed when using up to 20 times the expected dose of SkinBiotix® for up to 15 days (RNS: November 7th 2018). One volunteer experienced irritation in response to the cream but this is not unusual in studies of this nature. Demonstrating that SkinBiotix® is a safe technology is one of the Company’s most important milestones.
SkinBioTherapeutics has engaged in discussions with a number of potential partners interested in its technology and skin health product applications.
Earlier this year, a material transfer agreement (MTA) was signed with a global consumer goods company (RNS: 3rd April 2018) which has subsequently been evaluating the technology in its own ‘in house’ assays. Discussions are also ongoing with a number of other national and international potential partners. Further details will be provided as these discussions progress.
Dr Cath O’Neill, CEO of SkinBioTherapeutics, commented:
“The board is pleased with the progress made so far during 2018 in achieving a number of important product development milestones which have taken the SkinBiotix® technology closer to commercialisation in a cosmetic skin product.
“SkinBiotix® can now be manufactured to a commercially relevant scale, freeze dried for extended shelf life and has been formulated into a skin cream which has shown no significant safety or irritancy effects in a human study. These milestones, both individually and collectively, have reduced development risk, changed the risk reward ratio and are intended to increase interest from potential global partners.
“The final phase of the recently commenced human studies will be used to confirm product effectiveness, allowing us to complete the data pack to share with potential global partners who may be interested in commercialising the SkinBiotix® technology in the cosmetic skin care market.”20th November, 2018