Inflammatory Bowel Disease
December 9, 2013
BioLineRx reported results of a phase IIa
trial of BL-7040 for the treatment of inflammatory
bowel disease (IBD). Twenty-two
patients were enrolled in the multi-center,
proof-of-concept clinical trial, and 16 patients
completed the study (five weeks of treatment
plus two weeks of follow-up). During the
five-week treatment period, patients received
12mg/day for up to three weeks, followed by
40mg/day for two additional weeks. 50% of
patients met the primary endpoint, while the
remaining patients demonstrated a stable
clinical condition or minor improvement.
56% of patients recorded a decrease in rectal
bleeding of at least one point and 69% had
a rectal-bleeding sub-score of one (and in six
of these 11 patients, no rectal bleeding was
seen at all). 50% of patients completing study
treatment also met the secondary endpoint
assessed by the partial Mayo score, while all
other patients were clinically stable or demonstrated
some improvement. Furthermore,
50% demonstrated mucosal healing evaluated
by endoscopy sub-score measurements.
The drug was highly safe and well-tolerated,
with very low incidence of drug related
mild-moderate adverse events (AE) and one
serious AE not related to BL-7040 treatment.
October 29, 2012
Teva Pharmaceutical released results from a phase IIa trial of laquinimod for Crohn’s disease (CD). This multi-center, randomized, double-blind, placebo-controlled study enrolled 180 patients with moderate to severe CD, based on a CD Activity Index (CDAI) of 220-450 and serum C-reactive protein (CRP) levels of >5mg/L or mucosal ulcerations evident on a recent endoscopy. Subjects received daily doses of laquinimod 0.5mg, 1mg, 1.5mg, 2mg, or placebo for eight weeks, with four weeks follow-up. Data demonstrated that laquinimod 0.5mg/day resulted in a robust, early and consistent effect on remission (48.3% versus 15.9% of patients, respectively) and response rates (62.1% versus 34.9% of patients, respectively) versus placebo. No effect was noted on remission/response at higher doses. The drug was well tolerated.
March 13, 2006
Novogen has issued positive results of a phase I trial of their investigational synthetic isoflavone analogue NV-52, for the treatment of inflammatory bowel disease. Pharmacokinetic results indicated a rapid absorption profile and fairly consistent bioavailability, with peak plasma concentration achieved approximately 4 hours after administration, and a plasma elimination half-life of 8 hours. In addition, safety data yielded no reported adverse events. This open-label study enrolled 6 healthy male volunteers at the Gold Coast Hospital in Australia, under the direction of Professor Laurie Howes. Subjects received single oral administrations of the drug.
December 2, 2002
Adolor reported positive results from a phase III trial investigating alvimopan for the treatment of opioid bowel dysfunction. The study enrolled 168 chronic users of opioids whose bowel function had been impaired. The primary endpoint, the proportion of subjects having a bowel movement within 8 hours after each dose compared to placebo reached statistical significance. The proportion of subjects who had at least one bowel movement was 43% for alvimopan (0.5 mg), 55% for alvimopan (1 mg) and 29% for placebo. Alvimopan was well tolerated and the most frequently occurring adverse events versus placebo, included, diarrhea, abdominal cramps, nausea and vomiting.
February 19, 2002
Positive results were reported from a phase I trial of NicOx's NCX 1015, a nitric oxide-releasing derivative of prednisolone being developed for the treatment of inflammatory bowel disease. The randomized, double-blind, placebo-controlled, parallel-group study evaluated a local delivery (enema) formulation of NCX 1015. Four single escalating doses of NCX 1015 were administered to healthy male volunteers. Thirty-two subjects were divided into groups of eight; in each group, six subjects received NCX 1015 and two received placebo. Results showed satisfactory overall safety and tolerability of the drug, and no serious or severe adverse events were reported.