Skinbiotherap. Regulatory News (SBTX)

17 February 2021

SkinBioTherapeutics plc

("SkinBioTherapeutics" or "the Company")

AxisBiotix-Ps™ food supplement consumer study commences

· Final study size of 265 from initial target of 200, following high demand for places

· AxisBiotix-Ps™ shipped to participants, with study to commence upon receipt of supplements

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 its AxisBiotix-Ps™ food supplement consumer study.

Further to research exploring the relationship between the gut and the skin, SkinBioTherapeutics, with its partner Winclove Probiotics B.V., developed a blend of bacterial strains in the form of a food supplement. The 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.

The food supplement blend has been named AxisBiotix-Ps™, and enrolment for a 'self-managed' consumer study of the supplement commenced in January 2021. Following an extremely high level of demand for participation in the study, the capacity was increased from 200 to 265 participants with the additional 65 places focussing on non-psoriatic conditions to explore the possible impact of probiotics on other skin conditions. The study will be monitored through a bespoke mobile device app, allowing for the study to progress amid COVID-19 restrictions.

Participants have been grouped into cohorts and supplements have been shipped to the first cohort who, upon receipt, will download the AxisBiotix-Ps™ 'BRIGHT' consumer study mobile device application and commence the study. Participants will receive two batches of supplements, each batch comprising 28 days of supply. After each 7-day cycle, participants will be asked to respond to questions on the app, evaluating the progression of their symptoms, and will have the option to upload photos of the affected skin areas.

Following the 2 x 28-day periods, there will be a period of approximately 14 days where participants will continue to evaluate the progress of their symptoms, in order to assess the effects following cessation of taking the supplement.

The study is targeted to conclude by the end of April 2021 and, following analysis of the data, 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.

Stuart Ashman, CEO of SkinBioTherapeutics, said:

"I am extremely proud that, despite the global impact of COVID-19 restrictions and the new import regulations pertaining to Brexit, we have received the study samples of AxisBiotix-Ps™, from our partners at Winclove, and have begun shipping the units to the study participants. It is a reflection of the hard work of the team that we have managed to deliver on our target of commencing the food supplement consumer study by mid-Q1, despite these external factors.

"The increased size of the study allows us to widen our scope to assess the impact of AxisBiotix-Ps on the symptoms of other skin conditions beyond psoriasis; this is an exciting scope of research that will run concurrently with the primary trajectory of AxisBiotix-Ps.

"We look forward to engaging directly with the study participants and monitoring the impact of AxisBiotix-Ps on their skin and overall health."

-Ends-

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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.