Skinbiotherap. Regulatory News (SBTX)

13 January 2021

SkinBioTherapeutics plc

("SkinBioTherapeutics" or "the Company")

Enrolment for AxisBiotix-Ps™ food supplement consumer study commences

· Enrolment commenced for the AxisBiotix-Ps™ food supplement consumer study

· Targeting 200+ applicants, study will be monitored through a smart phone application

· Study due to commence in February 2021

SkinBioTherapeutics plc (AIM: SBTX), a life science company focused on skin health, announces that AxisBiotix Limited, a wholly owned subsidiary of the Company, has commenced enrolment for its food supplement consumer study.

AxisBiotix-Ps™ food supplement consumer study

Further to research exploring the relationship between the gut and the skin and the scientific evidence pointing to a link between gut dysfunction, stress-induced alterations to the gut microbiome and skin inflammation, the Company has been working with Winclove Probiotics B.V. ("Winclove") for the development of a blend of bacterial strains as a food supplement.

A proprietary blend of bacterial strains has been specifically designed to balance the gut microbiome to address the over production of new skin cells often seen in aggressive skin conditions such as psoriasis. Psoriasis is a debilitating skin condition caused by a malfunction of the immune system whereby raised 'plaques' form on the skin, which can be flaky, scaly and itchy. There is currently no cure for psoriasis; therapies tend to be steroid-based, which cannot be used long term and have side effects. The condition is common, with approximately 2% of the global population believed to suffer from psoriasis.

With Winclove having completed formulation and manufacture of the supplement, and unable to initiate its clinic based human study due to the Covid-19 restrictions, the Company has established a protocol for a 'self-managed' food supplement study.

The study, which will accept approximately 200 applicants, is now open for enrolment through the website www.axisbiotix.com. The participants will be asked to take a powdered food supplement dissolved in a glass of water on a daily basis and the study will run for a total of 56 days (2 x 28-day blocks). Thereafter the data will be collated and analysed to assess the impact the supplement has had on the health of the skin. The study is monitored through a mobile phone application with frequent questions for participants and the submission of photographs of affected areas taken using their smart devices. As such the study is not impacted by current COVID restrictions.

The supplements have been manufactured by Winclove and are currently being packaged ahead of shipment to the Company in early February. The supplements will then be dispatched to the study participants with an expected start date before the end of February 2021. The study will conclude before the end of April 2021 and the Company expects to be able to report on the study findings shortly thereafter. Subject to a positive outcome, the Company will then target a commercial launch of the product during the course of 2021 and in parallel initiate a clinic based study looking at specific markers.

Stuart Ashman, CEO of SkinBioTherapeutics, said:

"2020 was a year of transition for SkinBioTherapeutics with a focus on flexibility. We managed a smooth evolution from research into development, and proactively managed our way around the ever changing obstacles that the global pandemic presented and continues to present.

"The preparatory work carried out last year has ensured that we remain on track with all our strategic and commercial goals as we move into 2021, where we expect to see significant progress across several of our strategic channels. The launch of the AxisBiotix™ website and the recruitment of candidates for our AxisBiotix-Ps™ study, as well as the ongoing progress made by Sederma with our skin care programme, heralds the start of our commercialisation drive."

-Ends- 

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. 

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About SkinBioTherapeutics plc

SkinBioTherapeutics is a life science company focused on skin health. The Company's proprietary platform technology, SkinBiotix®, is based upon discoveries made by Prof. Catherine O'Neill and Professor Andrew McBain.

The Company has demonstrated, through scientific testing, that the SkinBiotix® platform can improve the barrier effect of skin models, protect from infection and repair wounds. Proof of principle studies have also shown that the SkinBiotix® platform has beneficial attributes applicable to each of these areas. The technology achieved positive results in clinical studies in human volunteers in early 2019.

The Company listed on AIM in April 2017 and is based in Manchester, UK. For more information, visit: www.skinbiotix.com.