Israel-based BioLineRx has released additional Phase IIa results of its oral drug BL-7040, which showed significant improvement of disease measurements in biopsies taken from inflammatory bowel disease (IBD) patients.
Biopsies have been taken from enrolled participants in the trial before and after treatment, in order to carry out the histological and biochemical analyses.
The gathered biopsies from each time point were randomly assigned to either a histological evaluation or to an assessment for levels of cytokines, considered as pro-inflammatory bio-markers.
According to the company, the analyses of inflammation indicators strengthens the initial positive results of the trial, released in April, which demonstrated that the drug is safe and effective in treating ulcerative colitis, a form of IBD.
The histological results demonstrate that neutrophil levels were significantly reduced in patients treated with BL-7040.
BioLineRx CEO Kinneret Savitsky said the positive results are an extension of the initial positive results of the Phase IIa trial for BL-7040, which showed that the drug is both safe and effective in treating ulcerative colitis.
"The clinical improvement in this trial was achieved after a relatively short treatment period, which leads us to believe that BL-7040 would have an even stronger beneficial effect after longer treatment duration," Savitsky said.
"The new results, which show that BL-7040 significantly reduces inflammatory factors, such as neutrophils and cytokines, support BL-7040’s mechanism of action, the ability to suppress the specific processes underlying the disease."
Neutrophils are the major cellular participants in acute inflammation, and their presence in the colon mucosa is expected to play a major role in causing tissue damage and clinical symptoms in IBD patients.
The company said that neutrophil levels are known to decrease when a patient’s clinical condition improves and in this respect, all patients whose neutrophil levels were reduced also demonstrated a clinical improvement as assessed by their Mayo score, the gold standard for evaluating ulcerative colitis therapy.
An additional measure of disease severity is the level of the pro-inflammatory cytokine, interleukin 6 (IL-6), which is the predominant cytokine found in inflamed areas in ulcerative colitis patients, and its concentration correlates with the Mayo endoscopic score for disease severity.
The trial also showed that IL-6 levels were also reduced in patients treated with BL-7040, and most patients with reduced cytokine levels demonstrated clinical improvement.
According to BioLineRx, the drug was safe and well-tolerated by the study participants, with very low incidence of drug related mild-moderate adverse events (AE) and one serious AE not related to BL-7040 treatment.
BL-7040 was invented by Prof Hermona Soreq from the Hebrew University of Jerusalem, and is an orally available, synthetic oligonucleotide with a unique dual activity, being developed for the treatment of IBD.
It is being developed by BioLineRx under a worldwide exclusive licence from Yissum Research and Development Company, the technology transfer company of the Hebrew University.
The two IBD forms, Crohn’s disease and ulcerative colitis are prevalent conditions that affect the quality of life of millions of people worldwide and about 1.4 million people are estimated to suffer from these diseases in the US.
Image: Histopathological image of the active stage of ulcerative colitis. Photo: courtesy of KGH.