Please can you introduce Servatus Biopharmaceuticals?
Servatus is an Australian-based Biopharmaceutical company established in 2012 and began operations in 2013. Based on the Sunshine Coast in Queensland, Servatus employs a team of highly skilled researchers from Clinical, Production, Engineering, Quality and Laboratory. With a state-of-the-art production facility, Servatus has the capabilities to ferment, concentrate, and dry its bacterial drug substances with a global first biomanufacturing process using a proprietary closed system with continuous production controlled by process automation with an Australian first electro spray drying at low temperatures to improve both yields and production costs.
Servatus is developing two novel drug platforms; pharmaceutical grade Live Biotherapeutic Products (LBPs) and recombinant proteins as first-line and adjunct therapies to treat a range of infectious, inflammatory and autoimmune conditions. LBPs are recognised by the FDA as live bacterial strains used to treat, cure and/or prevent disease and other medical conditions. Servatus has isolated, characterised and investigated specific microbial strains for targeted therapeutic actions in the areas of autoimmune, gastrointestinal, dermatological and infectious diseases. While orally delivered, the LBPs not only act locally within the gastrointestinal tract but act systemically throughout the body at target organ sites such as the joints, skin and brain via secretion of signalling molecules and modulation of the hosts immune system regulating inflammatory processes.
Where does research look promising in expanding past gastrointestinal diseases?
Servatus is developing LBP drugs to treat debilitating gastrointestinal diseases such as Ulcerative Colitis, chronic constipation, and gastric infections such as Helicobacter pylori. Servatus recognises the role of the microbiome ventures far beyond the gastrointestinal tract and is proud to be leading research in the areas of Inflammatory Bowel Disease, Rheumatology, Dermatology and Infection. To date, Servatus has achieved its primary outcome of safety and efficacy in stage 1 of a 2-Stage Phase I clinical trial in H. pylori infection, with stage 2 currently underway. A Phase I clinical trial assessing efficacy in Idiopathic Chronic Constipation is near completion; a Phase I/II study assessing an LBP to treat Insomnia will begin in January 2022 and a Phase I/II study assessing an LBP in treating Rheumatoid arthritis in patients who are non-responders to methotrexate therapy will begin March 2022. A Phase I study assessing safety and efficacy of an LBP in treating mild-moderate Ulcerative Colitis is currently undergoing an Investigation New Drug (IND) application with the FDA and a clinical trial to assess an LBP in treating Psoriasis is planned to begin Q2 in 2022.
What are you most looking forward to at the Microbiome Connect Gut Therapeutics 2021 conference?
I am thrilled to be a part of this International conference and driving forward discussions about the importance of the microbiome in human health. I am looking forward to sharing the progress we are making at Servatus and also learning what others are currently achieving in the microbiome space.