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.
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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.