It was initially meant to include 200 people but the number rose to 265 following high demand for places, the AIM-listed firm said, after enrolment commenced in January.
READ: SkinBioTherapeutics expands food supplement study after receiving an “extraordinary” number of applications
The additional 65 places are for patients suffering from non-psoriatic conditions to explore the possible impact of probiotics on other skin conditions, the life sciences firm noted.
The study will be monitored through a bespoke mobile device app to respect COVID-19 restrictions.
SkinBioTherapeutics, which has been exploring the relationship between the gut and the skin, developed a blend of bacterial strains in the form of a food supplement with its partner Winclove Probiotics.
The blend of bacterial strains has been designed to balance the gut microbiome to address the over-production of new skin cells often seen in aggressive skin conditions, such as psoriasis.
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.
They will receive two batches of supplements with each one covering 28 days of supply.
After each 7-day cycle, they 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 two 28-day periods, there will be a period of 14 days where participants will continue to evaluate the progress of their symptoms, so they can assess the effects following cessation of taking the supplement, the firm said.
The study is targeted to conclude by the end of April 2021 and, following analysis of the data, the company said it expects to be able to report on the study findings shortly thereafter.
If positive, it will target a commercial launch of the product during the course of 2021.
“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,” commented chief executive Stuart Ashman in a release.
“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.”
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