Skinbiotherap. Regulatory News (SBTX)

26 May 2021

SkinBioTherapeutics plc

("SkinBioTherapeutics" or "the Company")

Positive data for AxisBiotix-Ps™ food supplement consumer study unveiled 

· Positive feedback from participants with a range of skin conditions;

· Participants who self-identified as having psoriasis reported:

o Reductions in skin itchiness (76%), redness (75%), irritability (73%), flakiness (65%);

o Noticeable improvements in overall feelings of health and wellness.

· No safety concerns;

· Pre-registration open for customers at www.axisbiotix.com;

· Commercial preparations underway for launch in Q4 2021.

SkinBioTherapeutics plc (AIM: SBTX), a life science company focused on skin health, announces that AxisBiotix Limited ("AxisBiotix"), a wholly owned subsidiary of the Company, has finalised the analysis of the data from its AxisBiotix-Ps™ food supplement consumer study. Participant feedback was highly positive and there were no safety concerns.

AxisBiotix, with its partner Winclove Probiotics B.V., developed a proprietary blend of bacterial strains in the form of a food supplement called AxisBiotix-Ps™. The powdered supplement is specifically designed to modulate the immune system by harnessing the gut-skin axis, to address problems associated with sensitive skin conditions such as psoriasis.

Study results

The 56 day 'self-managed' consumer study of the food supplement blend, AxisBiotix-Ps™, commenced in February 2021. The participants that self-identified as suffering from psoriasis and completed the study reported the following results:

· 76% reported that their skin felt less itchy;

· 75% reported that their skin appeared less red;

· 73% reported that their skin felt less irritable; and

· 65% reported that they had fewer 'flaky patches' of skin.

Participants who responded positively about their skin health, also reported positive changes to their lifestyle. On average, at day 56:

· 62% reported having more energy;

· 64% reported better sleep; and

· 66% reported positive changes to their general mood.

Of participants that enrolled onto the study, 177 identified themselves as suffering from mild to moderate psoriasis. Of these, 142 commenced the study and completed the day 7 questionnaire with 91 reporting for the entire 56 day study period. The study results are calculated on the basis of the feedback from the 91 participants who reported for the entire period.

Prof. Cath O'Neill, Chief Scientific Officer of SkinBioTherapeutics, said:

"The results have exceeded our expectations, with improvements across all the key markers for irritable skin conditions like psoriasis - from skin itchiness to redness and the level of flaky patches. We have also received highly positive feedback from participants about improvements to their sense of wellbeing, such as being able to sleep better and pursuing activities they enjoyed before, such as painting, long walks and even wearing shorts, which they had given up because of their condition.

"I would like to thank the team and recognise their determination and skill to execute the AxisBiotix-Ps™ consumer study in very challenging circumstances presented by COVID-19. This required a rapid switch from a clinical-based study to a home-based one, using a mobile app."

Commercial plans - next steps

SkinBioTherapeutics, through its subsidiary, AxisBiotix, is targeting a commercial launch of theAxisBiotix-Ps™ product in Q4 2021.

The strategy for launch will be a monthly subscription model and during the first phase rollout will be controlled to both establish the supply chain and ensure subscribers have a reliable and consistent supply of product.

AxisBiotix will be seeking regulatory approval for the product as a food supplement in parallel in the UK, US and Europe, with the intention to launch within these regions post the respective approvals.

The Company will update on the plans for commercialisation, including targeted levels of subscribers during the initial launch period, within 90 days of this announcement.

AxisBiotix is encouraging individuals to pre-register for the product prior to its launch at www.axisbiotix.com.

Stuart Ashman, CEO of SkinBioTherapeutics, said:

"I am delighted with the results of the study; the data and testimonials are hugely encouraging. The next step for the Company is to drive forward the commercialisation process in order to launch the product in Q4 this year. Given this is a food supplement and as such needs to taken on a daily basis, we want customers to know that it will always be available to them, therefore, initially, we will be releasing subscriptions on a controlled basis to ensure a robust supply line. We therefore urge anyone interested in AxisBiotix-Ps™ to pre-register at www.axisbiotix.com.

"I am extremely proud that over the past 18 months, despite a global pandemic, we have evolved from being a wholly research-focused company to readying for our first commercial launch. This will be our first product on the market when it is launched later this year. We also have a range of other development programmes coming through. This a very exciting time for SkinBioTherapeutics."

To watch the SkinBioTherapeutics team talk through the results and listen to a selection of participants speak about their experience with AxisBiotix-Ps™, together with a full summary of the results, please visit the AxisBiotix website: www.axisbiotix.com.

-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.

About Psoriasis

Psoriasis is an autoimmune condition, which causes symptoms on the skin and sometimes the joints. It is caused by an acceleration of the skin replacement process, taking just a few days to replace skin cells that usually take 21-28 days. As a result of this process, there is an accumulation of skin cells that build up and result in raised 'plaques' on the skin. These plaques can be itchy, flaky, scaly and can look red on caucasian skin or darker patches on darker skin tones. Psoriasis can occur on any area of the body, including the scalp, hands, feet and back.

Incidence: psoriasis is believed to affect between 2-3% of the UK population (c.1.8 million people) and up to 125 million people worldwide [source: www.psoriasis.org]. The condition can occur at any age and currently, there is no cure - mainstay treatments are typically steroid or immuno suppressant-based.