A new phase I clinical trial will be beginning in the new year for a novel, live-bacterial biotherapeutic treatment for chronic functional constipation. The first patients are expected to begin treatment in the first half of January 2021.
The trial will focus on chronic idiopathic constipation (CIC) and constipation predominant IBS (IBS-C), which are forms of constipation where no known physical (anatomical) or physiological (hormonal or other body chemistry) cause has been identified.
Chronic constipation is a prevalent gastrointestinal condition that globally affects ~16% of all adults, and ~33.5% of people aged over 60. Further, as only ~22% of people with chronic constipation seek treatment from a healthcare provider, these numbers may actually be much higher. It ranks among the top 5 common Physician diagnoses for gastrointestinal (GI) tract disorders, with total medical costs for constipation estimated to be in excess of $230 million USD annually.
Patients suffering from chronic constipation tend to have lower general health, mental health, and social functioning scores than non-sufferers, and their mental and physical scores are comparable to people suffering from Crohn disease, gastroesophageal reflux, hypertension, diabetes, and depression. Chronic constipation is commonly treated with dietary fiber supplementation, laxatives, antidepressant drugs, or amendments to diet and activity levels. However, a large proportion of patients are dissatisfied with their current treatments, either due to safety concerns or lack of efficacy; therefore, alternative treatment options need to be explored.
Novel drug development at Servatus Ltd has identified a number of unique bacterial strains which will be tested in this clinical trial as an alternative to traditional treatments for chronic functional constipation. It is hoped that microbial therapeutic treatments may, not only alleviate symptoms of chronic constipation, but in some cases may cure chronic constipation by modulating the microbiome of the GI tract, and gut-brain axis.
Servatus Ltd, is an Australian-based biopharmaceutical company developing novel treatments for a range of autoimmune, inflammatory, gastrointestinal, and dermatological conditions. Servatus has two streams of drug development and research: engineered proteins for treatment of immune-mediated inflammatory diseases, and pharmaceutical-grade live microbial biotherapeutic treatments for treatment of chronic constipation, and recently for H.pylori infection (see previous news releases for information).
More news to follow: Servatus are also excited to announce that an FDA study for treatment of ulcerative colitis is planned to go ahead in the first half of 2021, with Dr Jessica Allegretti of Harvard Medical School / Brigham Womens Hospital as Principal Investigator.
Drossman, D.A., Li, Z., Andruzzi, E. et al. U. S. Householder survey of functional gastrointestinal disorders. Digest Dis Sci 38, 1569–1580 (1993). https://doi.org/10.1007/BF01303162
Bharucha, A.E., and Wald, A. (2019) Chronic Constipation. Mayo Clinic Proceedings, Volume 94, Issue 11, 2340 – 2357. https://doi.org/10.1016/j.mayocp.2019.01.031
Johanson JF, Kralstein J. Chronic constipation: a survey of the patient perspective. Aliment Pharmacol Ther. 2007 Mar 1;25(5):599-608. https://doi.org/10.1111/j.1365-2036.2006.03238.x. PMID: 17305761.
The Phase I trial is being conducted at the Princess Alexandra hospital in Brisbane and aims to create a new ‘non-antibiotic’ based treatment for H. pylori infection. If left untreated, H. pylori infection can cause gastritis (inflammation of the lining of the stomach) and can lead to further complications such as stomach ulcers. Currently, H. pylori infection is treated with two different antibiotics as well as stomach acid supressing drugs. However, side effects occur in up to 20% of patients and compliance with taking the full treatment course is a common reason for eradication failure. New treatments developed and produced by Servatus Ltd would offer people with H. pylori infection an alternative to these traditional treatments.
Servatus Ltd, which is based in Queensland, Australia, is a biopharmaceutical company developing novel treatments for a range of autoimmune, inflammatory, gastrointestinal, and dermatological conditions. The company has two main streams of drug development and research: engineered proteins selected for their immune-modulating activity to treat immune-mediated inflammatory diseases, and pharmaceutical-grade live microbial biotherapeutic treatments, such as the one developed for the treatment of H. pylori infection.
Servatus is developing alternatives to antibiotic-based treatments so they can help to reduce the occurrence of antibiotic resistance to common bacterial pathogens, whilst also providing safe and highly effective treatments to patients in which further disturbances to the microbiome are avoided.
Servatus appoints Hugh Alsop as Non-Executive Director and expands clinical programs team with Dr. Jessica Allegretti
Sunshine Coast, Australia – 3 March 2020.
Servatus Ltd (Servatus) is pleased to announce two key appointments as it continues to execute on its strategy to build a leading biopharmaceutical company in Australia.
Firstly, to further strengthen our development and commercialisation skills, Hugh Alsop has been appointed as a non-executive director. Hugh brings significant expertise as Servatus continues to advance its development programs and build its biopharmaceutical production capability. Secondly, Dr. Jessica Allegretti, an internationally recognised gastroenterologist and microbiome expert based at Harvard University, has been appointed as the principal investigator for Servatus’ upcoming clinical trials in ulcerative colitis, a chronic Inflammatory Bowel Disease (IBD). Dr Allegretti will also be a key research and clinical adviser for the company, as it aims to deliver first line and adjunct treatments for select autoimmune, gastrointestinal and dermatological conditions.
Mr. Alsop brings over 22 years of experience as a biotech executive to Servatus, with his deep understanding of drug development and pharmaceutical commercialisation making him a strong addition to the board. Hugh currently holds the role of Chief Executive Officer for Kinoxis Therapeutics, a private Australian biotech company.
“Hugh has a strong track record in growing companies the pharmaceutical and biotechnology industries and Servatus plans to leverage his experience as we move forward with two major clinical studies in 2020, and complete construction and commissioning of our joint venture facility on the Sunshine Coast,” said Servatus CEO and Executive Director Dr. Wayne Finlayson.
The appointment of Dr. Allegretti will add significant clinical, IBD and microbiome research experience to the Servatus team. She currently serves as Director of Clinical Trials at Brigham and Women’s Hospital Crohn’s and Colitis Centre. In addition to her clinical responsibilities and caring for patients, Dr. Allegretti is the Director of the Fecal Microbiota Transplant Program and an attending Gastroenterologist at Brigham and Women’s Hospital (a Harvard Medical School teaching hospital). Dr. Allegretti graduated from Cornell University in Ithaca, New York, and the Miller School of Medicine at the University of Miami in Miami, Florida. She was trained in internal medicine at Massachusetts General Hospital and completed her gastroenterology fellowship training at Brigham and Women’s Hospital. She later went on to receive a Master of Public Health from the Harvard School of Public Health.
Servatus will work with Dr. Allegretti in the design of its upcoming clinical trial in ulcerative colitis, using the highly successful preclinical results with Charles River Laboratory as the platform for the next phase of research into developing biotherapeutic treatments for inflammatory bowel disease (IBD).
“Dr. Allegretti’s impressive experience in patient care and clinical research lends considerable perspective to the design of our clinical trial,” said Dr. Finlayson. “She has already made significant contributions to the gastroenterology field and her leadership in our clinical program will set the pace as we accelerate our biotherapeutic-based drug development programs.”
“The preclinical results that Servatus have achieved are very promising in developing an alternative microbiome-based therapy for IBD patients, and I’m eager to begin work alongside its scientists for this next set of clinical trials,” said Dr. Allegretti.
“Servatus has already accomplished a tremendous amount of work in establishing the foundations for its research,” said Mr. Alsop. “I’m excited to be a part of the team as we explore the developmental opportunities alongside Dr. Allegretti.”
Servatus CEO Dr Wayne Finlayson was interviewed by Charles River’s Director of In Vivo Pharmacology Dr Rana Samadfam about microbial biotherapeutics and their application in treatments for IBD, arthritis and other autoimmune diseases at the 2019 Microbiome Movement Drug Development Summit in Boston.
Servatus welcomes Mark Williams as a non-executive director in February 2018
Mark joined the Servatus Board as a non-executive director in February 2018. Mark has had a long career in investment banking having spent nearly 20 years with Macquarie Bank in Sydney, London and South America.
Mark’s banking and commercial experience is very broad. He has significant risk, structured lending, governance, commodities & equities markets and management experience.
In 2001 Mark left Australia to set up Macquarie’s off-shore risk function in London. From 2004 to 2014 Mark was based in Sao Paulo, Brazil, initially in charge of the bank’s structured commodity lending then later as office and local country head. Mark, as an Executive Director, was responsible for Macquarie’s Brazilian commodity platform including management of a number of the bank’s largest global commodity clients.
He has extensive practical experience in corporate and government relationships, sales, management and strategy.
Mark has a BComm/LLB (Hons) from The Australian National University. He speaks Portuguese and Spanish.
Servatus Ltd Moves offices to the University of the Sunshine Coast
April 2017 saw Servatus Ltd relocating to the University of the Sunshine Coast, with laboratories set up on the university campus and offices just minutes away in the renowned Innovation Centre. Located in one of the country's fastest growing regions, the University of the Sunshine Coast campus at Sippy Downs has grown to accommodate more than 10,000 students since opening in 1996.
“We have found USC very progressive in its thinking and very willing to accommodate industry linkages that will benefit both.” said Managing Director Dr Wayne Finlayson. Servatus look forward to developing and strengthening the relationship with the University and its students furthermore over time.
For Servatus, the construction of the Sunshine Coast University Hospital and the establishment of the clinical trials department at the University paves a pathway for ground-breaking opportunities in research directed at selectively improving specific characteristics of existing therapeutic proteins to enhance their clinical utility.
The Sunshine Coast area is expanding rapidly and offers a balance of lifestyle and innovation, as well as reduced costs of living in contrast to major cities. Located only an hour away from the State’s capital city of Brisbane, the Sunshine Coast has been affectionately known as the Silicon Valley of Australia. Servatus aims to launch projects in the near future, providing the university with employment opportunities for local graduates.
February 2017 New Director Appointed Michael Vitale joins the board of Servatus Ltd
In February 2017, Servatus expanded the board by appointing Michael Vitale as Non-Executive Director. From an extensive career in both the USA and Australia, Michael brings a lifetime of experience in the commercialisation of science to the company. Michael has a wealth of knowledge in commercialisation, research and teaching.
Michael has previously acted as a non-executive director in both listed and unlisted companies. His experience in the commercialisation of science and life sciences in particular makes Michael an invaluable addition to Servatus. Michael holds citizenships in both Australia and the US.
Together with our Executive Director Wayne Finlayson and Director Wolf Hanisch, Michael further enables the progression of Servatus and the proceeding of pre-clinical work before moving to clinical trials.
Michael holds tertiary qualifications in mathematics from Oakland University in Michigan and Darttmouth College in New Hampshire (PhD, Mathematics), as well as an MBA from Havard Business School in the USA. Throughout his career, Michael has held the position of Professor at a range of leading universities across Australia and the US.
Michael has been the adjunct professor for over two years at the University of Melbourne, where he teaches entrepreneurship to MBA students at the Melbourne Business School and to graduate students in the School of Engineering and the School of Information. He also co-teaches bio-design innovation in a unit jointly set up by the Melbourne Business School and the Melbourne School of Engineering.
Previously he was both professor and director at Monash University with positions at the Monash Asia-Pacific Centre for Science and Wealth Creation (2006 to 2012) and (2008 to 2015) the Faculty of Information Technology. Both of these roles involved a range of responsibilities across research, teaching, commercial and management functions.
Over his career, Michael has contributed to several books and written a large number of professional publications, journal articles, conference papers and case studies.
Michael chaired ASX-listed Medical Therapies Ltd, now Cellmid from 2005 to 2008. The company was involved in the commercialisation of anti-inflammatory and anti-cancer therapeutics and entered clinical trials with its first product in Feb 2008.
The addition of Michael expands the knowledge base and experience of Servatus immensely. Michael shares our vision of commercialising our proprietary technology working in due course with one or more corporate partners in the bio-pharmaceutical industry.
Servatus Pty Ltd changes status to Public unlisted company and is now Servatus Ltd
In December 2016, Servatus Pty Ltd changed its status from propriety limited to an unlisted public company, becoming Servatus Ltd. As our number of shareholders grow, we see this status change as a step forward in the company’s progress.
This change of status from propriety limited to unlisted public creates a higher level of transparency and aims to provide greater protection of the public. With this new status comes a number of certain requirements that must be met. An unlisted public company registered under the Corporations Act must have at least three directors, two of whom must be Australian residents. Servatus Ltd recently met this requirement with the addition of Michael Vitale, our newly appointed Non-Executive Director. Michael expands Servatus, bringing a comprehensive mix of commercial, research and teaching experience from a wide-ranging career in both the USA and Australia.
Servatus was established in 2012, initially beginning operations in 2013. Our early necessary operations for filing of our patent pending to protect our core technology was financed by a preliminary capital investment. Today, Servatus still holds a clear vision to commercialise our proprietary technology, working in due course with our core technology.
As Servatus continues to progress, the number of shareholders permitted for a propriety limited company approached its limits. This growth in shareholders and the objective to create more transparency within the company gives reason enough for the status change from propriety unlimited to unlisted public. Servatus continues to target development of biological treatments and drugs for chronic inflammatory and auto-immune diseases that work by new modes.