New diagnostics and treatment of inflammatory bowel diseases
|Coordinator||ITH Immune Therapy Holdings AB - ITH Immune Therapy Holdings AB, Stockholm|
|Funding from Vinnova||SEK 5 000 000|
|Project duration||November 2010 - November 2013|
Purpose and goal
The TLA concept was established as a treatment platform for immune mediated inflammatory diseases (IMIDs). Ulcerative colitis was the first application area due to ease of visually following the disease through endoscopy. After a successful Phase II placebo controlled clinical trial, ITH intends to further develop the treatment and diagnostics by exploring its scientific and clinical validity on patients with severe complications after sepsis, ARDS (acute respiratory distress syndrome).
Results and expected effects
Our work with immunological phenotyping of patient material gave us indications on biomarkers to monitor during the clinical trial. One biomarker, HLADRhi monocytes, was found to be significant and correlated with clinical response and treatment outcome. We have found a diagnostic tool that will help the gastroenterologists to steer treatment and monitor their patients in a personalized fashion. The TLA treatment together with its companion diagnostics received positive feedback in a key opinion leader evaluation, indicating a good way forward to market introduction.
Approach and implementation
The majority of milestones in the project were accomplished according to the planned timeline. We have produced a new medical device, screened for diagnostic markers, submitted regulatory applications and conducted a clinical trial. The TLA platform is now being validated for several IMIDs and pre-clinical work is on going for the TLA2 study. Our only hurdle has been the development of hybridoma antibodies for the identified biomarkers, which was initially not successful and then proven to require a to high investment to succeed and therefore not prioritized.