In-silico identification of predictive biomarkers of response of OM-85 bacterial extract in Atopic Dermatitis

A scientific poster on an in-silico clinical trial model on OM-851 for children with Atopic Dermatitis (AD) was presented by Novadiscovery (nova) at the European Academy of Allergy and Clinical Immunology (EAACI) congress held in Prague, Czech Republic earlier this month, on July, 1-3. A subset of immunological predictive biomarkers of response to OM-85 was identified within the in-silico framework, and the selection of virtual patients based on this subset of markers led to a better simulated efficacy. Nova is a Lyon-based company with more than 10 years of expertise on modeling and in-silico simulation aimed at streamlining clinical development programs and supporting decision-making. In collaboration with OM Pharma, nova developed a mechanistic model to describe key pathways and biomarkers influencing pediatric AD disease course, including the mechanisms driving the immune response dysregulation, the loss of skin barrier integrity and the perturbation of the skin microbiome. OM-85 is a bacterial lysate consisting mainly of cell membrane components obtained from eight different bacteria genera. It activates the innate immune system through different pathways and is registered for the prevention of recurrent respiratory tract infections. To investigate response to OM-85 treatment, the in-silico model was enriched with data on OM-85 ADME (absorption, distribution, metabolism, and excretion) and mechanism of action, including the immune activation tissues as well as the gut-skin axis. Coupling predictive biomarkers identification and OM-85 mechanism of action, an in silico clinical trial framework was developed to assess the evolution of AD severity in virtual populations treated with emollients, topical corticosteroids, and the bacterial lysate OM-85, and identify the best predictive biomarkers of response. Clinical scores commonly used in AD management (SCORAD and EASI) were used to evaluate the efficacy of the different treatments. In conclusion, a subset of immunological predictive biomarkers of response to OM-85 was identified within the in-silico framework, and the selection of virtual patients based on this subset of markers led to a better simulated efficacy. This in-silico approach suggested key design points for future clinical trials for pediatric AD, including the selection of clinical trial study populations, leading the way to optimal clinical development programs. LINK TO THE EAACI E-POSTER Results from this collaboration will be also presented at the American conference of Pharmacometrics (ACoP13) which will be held in Aurora Colorado, USA in October 30 – November, 2. LINK TO ACoP ABSTRACT LINK TO NOVA website 1: OM-85 bacterial extract is being currently investigated for children with moderate AD in a Phase 2a trial (https://www.clinicaltrials.gov/ct2/show/NCT05222516).

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