Servatus launches Australia's first human study into the effects of live biotherapeutics on insomnia

Study to look at the link between the gut microbiome and sleep,by treating patients who suffer from insomnia with live biotherapeutics

Phase I/II trial will run during 2022,with results expected in 2023

Close to 15% of the Australian population suffer from insomnia,with sleep disorders costing the economy and society around $51 billion annually

SYDNEY,March 23,2022 --Servatus Ltd,an Australian biopharmaceutical company delivering leading novel autoimmune and microbiome therapies,is pleased to announce it has begun recruitment for its Phase I/II clinical trial for insomnia at the Sleep Disorders Centre at The Prince Charles Hospital in Queensland. This is the first study to research the effects of live biotherapeutics on patients with clinically diagnosed insomnia in Australia.

The study will examine the safety and efficacy of the treatment across 50 patients over a 35 Day treatment period,with the aim to assess the effect the live biotherapeutic has on gut microbiome composition and function and its association with healthy sleep patterns.

Dr Deanne Curtin,Sleep Disorders Centre Director at the Prince Charles Hospital said,"There is a definable gap in the development of safe and effective long-term solutions for insomnia. Improving sleep habits and behaviour therapy are typically the first approach in managing insomnia but most people do not seek professional support and may turn to over-the-counter medications to self-medicate. However,current medications,whether prescribed or over-the-counter are for short-term use only,may have undesirable side effects and do not treat the underlying cause."

She continued,"To date,the role of the microbiome in sleep health has been under-recognised and under-researched. However,there is a link between the gut microbiome and sleep through modulating inflammation,regulating neurotransmitter synthesis and organising human circadian rhythm. That is why influencing the microbiome to a healthier composition could offer a promising new treatment option for insomnia."

Dr Wayne Finlayson,Servatus' CEO commented: "We are excited to begin recruitment for this important trial. It is a first for Australia and we hope it will enable better health outcomes for people suffering from insomnia. With an improved understanding of the microbiome-gut-brain axis and how the interaction between these organs may affect sleep,Servatus is hoping to deliver a new treatment for insomnia."

Insomnia Overview

Insomnia is a multi-faceted sleep disorder impeding both physical and mental performance. Cumulative effects of long-term sleep loss can result in adverse health outcomes,affecting neuroendocrine,metabolic and immune processes. These affects are often accompanied or preceded by other medical or psychiatric conditions such as diabetes,hypertension,heart disease,depression,substance abuse and Alzheimer's disease.1-4

According to the Sleep Health Foundation August 2021,more than half (59.4%) of the Australian population suffers from at least one chronic sleep symptom. 14.8% had chronic insomnia when classified by the International Classification of Sleep Disorders (Version. 3 Criteria). 5

The combined direct and indirect costs of sleep disorders to the Australian economy and society is $51 billion per annum. New analysis published in the Journal of Clinical Sleep Medicine 2021,estimated 13.6 million had at least one Sleep Disorder in the United States,equating to a conservative estimate of $94.9 billion in healthcare costs per annum.6

Trial Recruitment

The Servatus trial will run during 2022,with final results expected in 2023.

Anyone with symptoms of insomnia between the ages of 18 to 70 years interested in participating in the trial and can travel to The Price Charles Hospital in Brisbane,can register via the following website: https://trials.evrima.com.au/insomnia-medical-study

Robert Skelton,Labor MP; Wayne Finlayson,CEO,Servatus; Cameron Dick,treasurer for Queensland.

REFERENCES

1. Javaheri,S.,& Redline,S. Insomnia and Risk of Cardiovascular Disease. Chest. 2017;152(2),435–444.

2. Khurshid K. A. (2018). Comorbid Insomnia and Psychiatric Disorders: An Update. Innovations in Clinical Neuroscience. 2018;15(3-4),28–32.

3. Yuan,& Larsson,S. C. (2020). An atlas on risk factors for type 2 diabetes: a wide-angled Mendelian randomisation study. Diabetologia,63(11),2359-2371.

4. Phillip Huyett,Neil Bhattacharyya.2021. Incremental health care utilization and expenditures for sleep disorders in the United States.Journal of Clinical Sleep Medicine.

5. Dzierzewski,J. M.,Donovan,E. K.,Kay,D. B.,et al. (2020). Sleep Inconsistency and Markers of Inflammation. Frontiers in Neurology. 2020;11,1042.

6. Phillip Huyett,Neil Bhattacharyya.2021. Incremental health care utilization and expenditures for sleep disorders in the United States.Journal of Clinical Sleep Medicine.

About Servatus | www.servatus.com.au

Founded in 2012,Servatus Ltd is an Australian-owned biopharmaceutical company devoted to creating safe,effective,and reliable microbiome-based therapeutic drugs to treat several chronic and debilitating autoimmune diseases,as well as non-antibiotic treatments for bacterial infections. In addition to our innovative drug research and development,and ongoing clinical trials,Servatus also owns a state-of-the-art production facility. Our own production facility means that Servatus is able to oversee all aspects of the research development and production pipeline and ensure that our live microbial biotherapeutic drug candidates are made to our high-standard and specifications,and removes the logistical uncertainty often associated with outsourcing manufacturing. Servatus is an unlisted public company with headquarters in Coolum,Queensland. The Company derives its name from St Servatus who was a churchman and diplomat in the fourth century and become Bishop of Tongeren,a city and municipality now in modern-day Belgium. Servatus was invoked by Catholics as a patron saint,with healing powers for a range of ailments,including rheumatism.

About Microbial Biotherapeutics

A primary research focus for Servatus is the development of microbial biotherapeutics (live micro-organisms) which can be used to prevent or treat disease. Historically,the application of selected bacterial strains has been devoted to the modulation and repair of the gut microbiome. However,Servatus' research concentrates on developing microbial biotherapeutics that are applicable to the prevention,treatment or cure of specific diseases or conditions in humans. Servatus targets autoimmune and inflammatory conditions associated with dysbiosis and immune dysregulation,including ulcerative colitis,arthritis,atopic dermatitis,and gastrointestinal and urogenital tract infections. Servatus utilises bacterial strains that have not been widely employed previously. They have demonstrated bioactive properties that inhibit pathogenic bacterial growth and infection,modulate immune responses and regulate inflammatory signals. The efficacy of the bacterial strains is due to structures on their cell surface and,importantly,the biological effector molecules they secrete,which interact and communicate with the body's own cells. The bacterial candidates are developed to act directly at specific sites within the gastrointestinal tract and at targeted organ sites that are influenced by microbial interactions.