Inflammatory Bowel Disease

January 22, 2018

RedHill Biopharma reported top-line final results from the Phase II clinical study with BEKINDA 12mg (RHB-102) for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). An independent review and analysis of the final results, provided to the company, confirmed that the Phase II study with BEKINDA 12mg successfully met its primary endpoint, improving the primary efficacy outcome of stool consistency (per FDA guidance definition) by an absolute difference of 20.7% vs. placebo (p-value=0.036). The final top-line results improve upon the previously announced top-line results (absolute difference of 19.4%, p-value=0.05). Results from the BEKINDA Phase II study suggest that they compare favorably with previously reported efficacy outcome values from studies of Xifaxan (rifaximin) and Viberzi (eluxadoline) across all three efficacy endpoints. The randomized, double-blind, placebo-controlled Phase II study evaluated the efficacy and safety of BEKINDA 12mg in 126 subjects over 18 years old in the U.S., who received either BEKINDA 12 mg or placebo, once daily, for a period of eight weeks. RedHill plans to meet with the FDA in the first half of 2018 to discuss the design for one or two pivotal Phase III studies with BEKINDA 12mg for IBS-D.

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.