Skinbiotherap. Regulatory News (SBTX)

 SkinBioTherapeutics plc

("SkinBioTherapeutics" or "the Company")

SkinBioTherapeutics identifies blends for use in new consumer study into acne

· Two new formulas to be trialled side-by-side to compare efficacy against the most common skin condition

· Study to be conducted in partnership with Winclove Probiotics

· Consumer study on track to commence in Q4 2023

5 September 2023 - SkinBioTherapeutics plc (AIM: SBTX, or the Company), the life science business focused on skin health, has announced that it has chosen the probiotic blends it will use for the comparative studies for its consumer study in acne.

The two separate blends will be tested side-by-side in a consumer volunteer study to determine which has better efficacy. The Company is aiming to target the inflammatory pathways that are associated with irritable skin conditions like acne. The blends will be supplied to participants in powder-form for the study, however this may not be the final formulation form for a potential commercial product.

An independent third-party will conduct the study and run two separate cohorts in parallel to compare the efficacy of the respective formulas, which are being provided by Dutch food supplement provider Winclove Probiotics BV. 

The study is expected to commence in Q4 2023 and be complete by year end with results issued thereafter. Further details of the study will be disclosed by the end of Q3 2023. The benefit of undertaking a consumer study is the relatively short time and cost compared to a clinical study.

SkinBioTherapeutics has previously developed and marketed AxisBiotix PS™ - a probiotic food supplement for the treatment of psoriasis - which has strong consumer retention levels and is reported to be highly effective by users. The new acne formulation will be produced in a similar powder format to be taken daily, like AxisBiotix PS.

Acne is a skin condition that develops when pores get clogged with dead skin, bacteria, and dried skin oil buildup, which leads to redness, tenderness, pimples, nodules, or cysts primarily on the face, back, or chest. It can range from mild to severe and typically affects teenagers and young adults but anyone can be affected. Acne is thought to be caused by overactive oil glands, a slower cell shedding process, and higher levels of certain bacteria causing inflammation.

Up to 85% of people will suffer from acne at some point in their life. Although not life-threatening, acne can cause irritation and life-long scarring, and can negatively impact a person's mental health and self-esteem.

The strong desire to alleviate the symptoms makes the global acne market worth $9.4billion with CAGR of 4.8% (fortune business insights 2019). The UK acne therapeutics market size is at around $261 Mn in 2022 and is projected to reach $377 Mn in 2030, exhibiting a CAGR of 4.7%. 34 % of adults in the UK have experienced acne at some time in their lives and 11.5% of adults presently have acne. Overall, this means that acne is the most common skin condition and one of the top 10 most prevalent diseases worldwide.

Doctors currently treat severe acne with topical steroid creams, although oral medications can also be used. However, steroid medications can lead to undesirable side effects, including skin dryness, irritation, and rashes. Side effects from oral medications can be more severe such as depression or suicidal thoughts.

Stuart Ashman, CEO of SkinBioTherapeutics, said:

"There is an enormous market for acne treatment that we are eager to enter, and to provide those who struggle with the condition with a microbiome-based product that has the potential to alleviate their symptoms. The use of probiotic treatments for acne is relatively novel but could hold some major advantages over current treatments.

"Identifying the two blends we intend to use is another step forward in the preparation for our study in acne later this year. We have shown we can develop and commercialise products with the first being AxisBiotix-Ps™ which is now launched in three countries. An AxisBiotix programme for acne will be our second commercial product. We have learnt a lot from our first product development and launch; we are in a good position for the next one. 

 "We eagerly anticipate commencing and seeing the results of this study with a view to bringing a new formula to market."

-Ends-

The information communicated in this announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014.

For more information please contact:

Notes to Editors

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 Professor Catherine O'Neill and Professor Andrew McBain.

The Company is targeting a number of skin healthcare sectors, the most advanced of which are cosmetic skincare and food supplements to modulate the immune system by harnessing the gut-skin axis. In each area SkinBioTherapeutics plans to exemplify its technology through human studies. The Company's first product, AxisBiotix-Ps™, a food supplement to address the symptoms of mild to moderate psoriasis.

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