Pharmaceutical Business review

BioLineRx secures notice of allowance for US patent covering new celiac disease treatment

The company is dedicated to identifying, in-licensing and developing promising therapeutic candidates.

The patent, when issued, will be valid until at least 2026, while additional patents claiming the BL-7010 composition and use thereof are granted or pending in Europe, Japan, Canada, Israel, India, China, Brazil, Russia, Australia, South Africa and Hong Kong.

BioLineRx chief executive officer Kinneret Savitsky said the company is happy to have received a Notice of Allowance from the USPTO for the BL-7010 patent.

"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," Savitsky said.

"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 I/II trial, expected in the next few weeks, which will enable selection of the optimal dose for future development."

Upon completion of the Phase I/II trial, the company intends to start a randomized, controlled efficacy study in celiac patients.

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 effectively masks them from enzymatic degradation and prevents the formation of immunogenic peptides that trigger the immune system.