Enrollment Begins for Food Supplement, Skin Inflammation Study

February 2, 2021
Morgan Petronelli, Associate Editor

A proprietary food supplement designed to balance the gut microbiome and target the over production of skin cells will be examined in an upcoming consumer study that has recently announced participant enrollment.

SkinBioTherapeutics, announced its wholly owned subsidiary, AxisBiotix Limited, has initiated enrollment for its food supplement consumer study, according to a company press release.1

The study will be focused on examining the relationship between the skin and gut, and scientific evidence pointing to a link between gut dysfunction, skin inflammation, and stress-induced alterations to the gut microbiome.

AxisBiotix-Ps, a food supplement developed in partnership with Winclove Probiotics B.V, consists of a proprietary blend of bacterial strains that are designed to balance the gut microbiome in an effort to tackle the over production of new skin cells seen in conditions like psoriasis.

Following the completion of formulation and manufacturing of the supplement, a clinical study was unable to start due to COVID-19 restrictions. Since then, SkinBioTherapeutics has set forth a protocol for a “self-managed” food supplement study.

"2020 was a year of transition for SkinBioTherapeutics with a focus on flexibility,” said Stuart Ashman, CEO of SkinBioTherapeutics, in a press release. “We managed a smooth evolution from research into development, and proactively managed our way around the everchanging obstacles that the global pandemic presented and continues to present.”

The study will be accepting 200 participants to take the powdered food supplement, which will be dissolved in a glass of water, once daily for 56 days (2 x 28-day blocks) and will be monitored through a mobile phone app that will consist of frequent questions and image submissions of any affected areas.

The study will commence before the end of February 2021 and conclude before the end of April 2021, according to SkinBioTherapeutics, with findings from the study expected shortly thereafter.

Depending on positive results from the consumer study, the company plans on a 2021 commercial launch of AxisBiotix-Ps and will launch a clinic-based study looking at specific markers.

"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,” said Ashman. “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 skincare program, heralds the start of our commercialization drive."

Click here for more information and to enroll in the consumer study.

Reference:

1. Enrolment for AxisBiotix-PsTM food supplement consumer study commences. Pharmiweb.co . https://www.pharmiweb.com/press-release/2021-01-13/enrolment-for-axisbiotix-ps-food-supplement-consumer-study-commences. Published January 13, 2021. Accessed February 2, 2021.