TIDMSBTX
RNS Number : 8304H
SkinBioTherapeutics PLC
20 November 2018
SkinBioTherapeutics plc
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(R) 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(R) 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(R) 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(R)
technology
Having previously only manufactured the SkinBiotix(R) 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(R) 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(R)
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(R) 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 17(th) 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(R) for up to 15 days
(RNS: November 7(th) 2018). One volunteer experienced irritation in
response to the cream but this is not unusual in studies of this
nature. Demonstrating that SkinBiotix(R) is a safe technology is
one of the Company's most important milestones.
Commercial interest
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: 3(rd) 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(R) technology closer to
commercialisation in a cosmetic skin product.
"SkinBiotix(R) 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(R) technology in the
cosmetic skin care market."
The information communicated within this announcement is deemed
to constitute inside information as stipulated under the Market
Abuse Regulations (EU) No. 596/2014 and has been arranged for
release by Doug Quinn, CFO of the Company. Upon the publication of
this announcement, this inside information is now considered to be
in the public domain.
-ENDS-
For more information, please contact:
SkinBioTherapeutics plc Tel: +44 (0) 161 468
Dr. Cath O'Neill, CEO 2760
Doug Quinn, CFO
Cairn Financial Advisers LLP (Nominated Tel: +44 (0) 20 7213
Adviser) 0880
Tony Rawlinson / Sandy Jamieson / Richard
Nash
Turner Pope Investments (Joint Broker) Tel: +44 (0) 20 3621
Ben Turner / James Pope 4120
Northland Capital Partners (Joint Broker)
Dugald Carlean Tel: +44 (0) 20 3861
6625
Instinctif Partners (Media Relations) Tel: +44 (0) 20 7457
Melanie Toyne-Sewell / Deborah Bell 2020
SkinBio@instinctif.com
About SkinBioTherapeutics plc
SkinBioTherapeutics is a life science company focused on skin
health. The Company's proprietary platform technology,
SkinBiotix(R), is based upon discoveries made by CEO Dr. Catherine
O'Neill and Professor Andrew McBain.
SkinBioTherapeutics' platform applies research discoveries made
on the activities of lysates derived from probiotic bacteria when
applied to the skin. The Company has shown that the SkinBiotix(R)
platform can improve the barrier effect of skin models, protect
skin models from infection and repair skin models. Proof of
principle studies have shown that the SkinBiotix(R) platform has
beneficial attributes applicable to each of these areas.
SkinBioTherapeutics received seed funding from the Tech Transfer
office of the University of Manchester for the discovery of
SkinBiotix(R). The platform was subsequently spun out of the
University of Manchester in March 2016 and was funded by OptiBiotix
(AIM: OPTI).
The Company joined AIM in April 2017 concurrent with raising
GBP4.5 million from a placing of new ordinary shares.
The Company is based in Manchester, UK. For more information,
visit www.skinbiotherapeutics.com.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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