Servatus Biopharmaceuticals announces next phase 1 clinical trial: a new microbiome-based therapeutic treatment for functional constipation.

7 January 2021

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.

References:

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.