Israel-based clinical-stage biopharmaceutical firm BioLineRx has started enrolment of patients in a Phase I/II trial of a novel, non-absorbable, orally available polymer BL-7010, to treat patients with celiac disease.
A total of 32 patients will be enrolled in the two-part (single and repeated), double-blind, placebo-controlled, dose escalation Phase I/II trial of BL-7010.
Primary objective is to evaluate the safety of single and repeated ascending doses of BL-7010 in well-controlled celiac patients, while the secondary objectives include an assessment of the systemic exposure, if any, of BL-7010 in these patients.
BioLineRx CEO Kinneret Savitsky said the start of BL-7010’s Phase I/II trial at Tampere Hospital in Finland is a major milestone in the development of one of the company’s most promising projects.
"Based on our pre-clinical results to date, we are very enthusiastic about this unique product, which is also generating a lot of excitement from both the scientific and medical communities," Savitsky said.
Celiac disease is a chronic, autoimmune, inflammatory condition which causes damage to the small intestine and is related with other autoimmune disorders, as well as with osteoporosis, infertility, neurological conditions and even cancer.
At present, there is no approved celiac therapeutics for the disease, which affects around 1% of the world’s population.
The only treatment currently available for the celiac disease is a gluten-free diet that is exceptionally difficult and costly to maintain, according to the company.
In addition, there are a very small number of clinical-stage projects currently being developed for this disease.
Results of the trial are expected to be released in mid-2014, to be followed by an efficacy study that will likely to start in the second half of 2014.
BL-7010 has a high-affinity for gliadins, the immunogenic proteins present in gluten that cause celiac disease.
The company said that by sequestering gliadins, BL-7010 masks them from enzymatic degradation and prevents the formation of immunogenic peptides that trigger the immune system.
Image: Biopsy of small bowel showing coeliac disease manifested by blunting of villi, crypt hyperplasia, and lymphocyte infiltration of crypts. Photo: courtesy of Samir.