Results of ongoing Phase 1/2 trial for BL-7010 expected in next few weeks
"We are very pleased to have received a Notice of Allowance from the USPTO for the BL-7010 patent," stated Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx. “BL-7010 for the treatment of celiac disease is one of our lead clinical programs. We are currently testing its safety and tolerability in a Phase 1/2 trial in well-controlled celiac patients. We previously announced successful completion of the single-dose escalation part of the study, and the 14-day, repeated administration part of the study is currently ongoing. We look forward to the results of this Phase 1/2 trial, expected in the next few weeks, which will enable selection of the optimal dose for future development. Following completion of this study, we plan to commence a randomized, controlled efficacy study in celiac patients,” concluded Dr. Savitsky.
BL-7010 is a novel, non-absorbable, orally available polymer intended for the treatment of celiac disease. It has a high affinity for gliadins, the immunogenic proteins present in gluten that cause celiac disease. By sequestering gliadins, BL-7010 effectively masks them from enzymatic degradation and prevents the formation of immunogenic peptides that trigger the immune system. This significantly reduces the immune response triggered by gluten. BL-7010 is excreted with gliadin from the digestive tract and is not absorbed into the blood. The safety and efficacy of BL-7010 were demonstrated in pre-clinical studies. BL-7010 was invented by Prof. Jean-Christophe Leroux from the Department of Chemistry and Applied Biosciences, Institute of Pharmaceutical Sciences, ETH Zurich,
About Celiac Disease
Celiac disease is a chronic, autoimmune, inflammatory disease of the small intestine characterized by damage to the lining of the small intestine and typically leads to dyspepsia, malabsorption and a variety of other symptoms. It occurs in genetically predisposed individuals and is caused by an immunological reaction to gluten, found in wheat, barley and rye. Estimates suggest that 1% of the world’s population is affected by celiac disease, and prevalence is expected to increase dramatically with improved diagnosis and awareness of the disease. The celiac market is projected to reach $8 billion by 2019. There are currently no treatments approved for celiac disease and the only treatment option is a life-long, strict, gluten-free diet, which is difficult to maintain both due to food contamination with gluten, as well as eating habits in a social setting.
BioLineRx is a publicly-traded, clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds primarily from academic institutions and biotech companies based in
BioLineRx’s current portfolio consists of a variety of clinical and
pre-clinical projects, including: BL-1040 for prevention of pathological
cardiac remodeling following a myocardial infarction, which has been
out-licensed to Bellerophon BCM (f/k/a
For more information on BioLineRx, please visit www.biolinerx.com
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access to the Company’s
Various statements in this release concerning BioLineRx’s future
expectations, including specifically those related to the development
and commercialization of BL-7010, constitute “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements include words such as “may,”
“expects,” “anticipates,” “believes,” and “intends,” and describe
opinions about future events. These forward-looking statements involve
known and unknown risks and uncertainties that may cause the actual
results, performance or achievements of BioLineRx to be materially
different from any future results, performance or achievements expressed
or implied by such forward-looking statements. Some of these risks are:
changes in relationships with collaborators; the impact of competitive
products and technological changes; risks relating to the development of
new products; and the ability to implement technological improvements.
These and other factors are more fully discussed in the “Risk Factors”
section of BioLineRx’s most recent annual report on Form 20-F filed with
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D., +1-212-375-2664
Andrew Mielach, +1-212-375-2694
for BioLineRx Ltd.
Tsipi Haitovsky, Public Relations