Servatus Ltd, an Australian biopharmaceutical company delivering leading novel autoimmune and microbiome therapies, is pleased to share that its first in human Phase 1/2 clinical trial for its live biotherapeutic insomnia treatment has shown positive results.
The randomized, double blinded, placebo-controlled trial was conducted at the Sleep Disorders Centre at The Prince Charles Hospital in Queensland. The trial examined the safety and efficacy of the treatment in 50 patients over 35 days and is now set to be expanded following the promising results. Between 50 and 125 participants will be recruited for the next phase, which will look to further verify the results seen in the Phase 1/2 trial as the treatment moves towards commercialisation.
Dr Deanne Curtin, Sleep Disorders Centre Director at the Prince Charles Hospital said, “Insomnia and other sleep disorders impact the majority of the population, with close to 60% of Australians suffering from at least one chronic sleep symptom. People often turn to over-the-counter medications and do not seek professional treatment for their sleep disorders, so the need for effective, long-term insomnia treatments are clear.
“Servatus’ live biotherapeutic treatment explores the role of the microbiome in sleep health and our preliminary results for the trial have been extremely promising. By expanding our trial with a dose ranging study we expect to produce more substantial data to demonstrate the effectiveness of this treatment option.”
Dr Wayne Finlayson, Servatus’ CEO commented: “The strong preliminary results from our Insomnia treatment trial indicate that there is indeed a link between the microbiome-gut-brain axis and its impact on sleep. With the trial expanding we are confident that we are moving closer to being able to provide an effective new treatment option for those suffering from 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. These affects are often accompanied or preceded by other serious medical or psychiatric conditions.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, with analysis estimating 13.6 million people in the United States having at least one disorder, representing a healthcare cost of at least $94.9 billion a year. 6
Interest in participating in the expanded trial can be registered at myclinicalstudy.com.au or by calling 07 3130 0820.
REFERENCES
- Javaheri, S., & Redline, S. Insomnia and Risk of Cardiovascular Disease. Chest. 2017;152(2), 435–444.
- Khurshid K. A. (2018). Comorbid Insomnia and Psychiatric Disorders: An Update. Innovations in Clinical Neuroscience. 2018;15(3-4), 28–32.
- Yuan, S., & Larsson, S. C. (2020). An atlas on risk factors for type 2 diabetes: a wide-angled Mendelian randomisation study. Diabetologia, 63(11), 2359-2371.
- Phillip Huyett, Neil Bhattacharyya. 2021. Incremental health care utilization and expenditures for sleep disorders in the United States. Journal of Clinical Sleep Medicine.
- Dzierzewski, J. M., Donovan, E. K., Kay, D. B., et al. (2020). Sleep Inconsistency and Markers of Inflammation. Frontiers in Neurology. 2020;11, 1042.
- Phillip Huyett, Neil Bhattacharyya. 2021. Incremental health care utilization and expenditures for sleep disorders in the United States. Journal of Clinical Sleep Medicine.
Key Facts:
· Preliminary results show promise for Servatus’ new microbiome-based treatment Insomnia
· Expanded trial to recruit more participants and move towards completion of Phase 2 trial
· Close to 15% of the Australian population suffer from insomnia, with sleep disorders costing the economy and society around $51 billion annually
About us:
About Live Biotherapeutics
Gut bacteria can impact diseases in various locations on the body, through modulation of the human immune system, metabolism and even neurological function. Live biotherapeutics are a new area of medicine based on identifying certain species and combinations of gut bacteria that have significant immunomodulatory, anti-microbial and hormone regulating roles.
Servatus’ live biotherapeutics are combinations of strains of commensal bacteria that have been carefully selected for their specific functionality relevant to mechanisms of disease.
About Servatus | www.servatus.com.au
Servatus Ltd is an unlisted public biopharmaceutical company focused on 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 drug research and development, and ongoing clinical trials, Servatus also owns a state-of-the-art production facility. This facility means Servatus is able to oversee all aspects of the research development and production pipeline and ensure that its live microbial biotherapeutic drug candidates are made to the highest-standard and specifications, and removes the logistical uncertainty often associated with outsourcing manufacturing.
Contact details:
Jack McLintock
+61 450 608 022