Date: 2013-04-17
Type of information: Results
phase: 2
Announcement: results
Company: BioLineRx (Israel)
Product: BL-7040
Action
mechanism: BL-7040 is an orally available, synthetic oligonucleotide with unique dual activity, being developed for the treatment of inflammatory bowel disease (IBD). It has a specific agonist effect on a receptor involved in the immune system and inflammatory reactions called Toll-Like Receptor 9 (TLR-9). It also acts as a specific suppressor of acetylcholinesterase, a key enzyme involved in neurological pathways. This combined effect gives it a unique combination of both neurological and anti-inflammatory properties. In addition BL-7040 has also an indirect effect on the production of pro-inflammatory cytokines as well as anti-inflammatory properties via modulation of macrophages.
Disease: inflammatory bowel disease (IBD)
ulcerative colitis
Therapeutic area: Inflammatory diseases
Country: Israel
Trial
details: This Phase II trial will be an open-label study to evaluate the efficacy, pharmacodynamics, safety and tolerability of oral BL-7040 in up to 20 patients with moderately active ulcerative colitis, a type of IBD. Patients will be treated for up to five weeks with BL-7040: 12mg/day for up to three weeks followed by 40mg/day for two additional weeks. The clinical trial was carried out five leading medical centers in Israel. (NCT01506362)
Latest
news: * On April 17, 2013, BioLineRx, a biopharmaceutical development company, has announced positive Phase IIa results for BL-7040, an orally available drug for treating inflammatory bowel disease (IBD). The study showed that BL-7040 is safe and effective in treating ulcerative colitis, a form of IBD.
Sixteen of the 22 patients who were enrolled in the clinical trial completed the full five-week course of treatment and two-week follow-up. The primary clinical endpoint in the study - a reduction in the Mayo score between baseline and completion of treatment – was achieved. Fifty percent of patients (8 patients) met the primary endpoint, while the remaining 8 patients demonstrated a stable clinical condition or minor improvement. Fifty-six percent of patients (9 patients) demonstrated decreases of at least 1 point in the rectal-bleeding sub-score and 69% (11 patients) had rectal-bleeding sub-scores of ?1 (in 6 of the 11 patients, no rectal bleeding was seen at all).
Fifty percent of the patients completing study treatment also met certain secondary endpoints, such as a partial Mayo score reduction and mucosal healing evaluated by endoscopy sub-score measurements. Additional secondary endpoints in the study were the IBD Quality-of-Life Questionnaire, and the serum CRP and fecal calprotectin measurements. The results of these additional secondary endpoints were not conclusive, although certain positive trends were noted.
BL-7040 was highly safe and well tolerated by the study participants, with a very low incidence of drug related, mild-to-moderate adverse events (AEs), as well as one serious adverse event (SAE) not related to the treatment. Both patients and investigators were very satisfied with the safety and tolerability profile of the treatment and, in particular, emphasized the ease of oral administration.
“Based on historical data, current steroidal or biological treatment regimens have yielded clinical response rates of between 30% and 70% in studies with significantly longer treatment periods; thus, the results of our five-week, proof-of-concept study suggest positive efficacy for BL-7040. A number of experts in the IBD field who have reviewed the results of our study all agree that these are very encouraging and positive results, and that the reduction in rectal bleeding is particularly impressive. Our immediate next steps include evaluating the most advantageous ways to progress with this therapeutic candidate from a clinical and business perspective, including examining potential additional indications. In parallel, we also plan to accelerate discussions with potential co-development and licensing partners for this asset," concluded Dr. Savitsky, CEO of Bioline RX.
* On March 5, 2012, BioLineRx has announced that it has received approval from the Israeli Ministry of Health for commencing a Phase II clinical trial of BL-7040, an orally available molecule for treating Inflammatory Bowel Disease. BL-7040 was shown to suppress inflammation in pre-clinical studies. In these studies, BL-7040 treatment led to amelioration of parameters associated with inflammatory bowel disease. BL-7040\'s efficacy in these studies was shown to be highly significant and comparable to that of dexamethasone, a steroid used routinely for IBD but which is associated with multiple side effects. BL-7040\'s safety was also demonstrated in pre-clinical studies, as well as in previous clinical trials.
