Viking Therapeutics announced results from the company’s Phase II study of VK5211 in patients recovering from hip fracture. The Phase II clinical trial was a randomized, double-blind, placebo-controlled, parallel group, international study designed to evaluate the efficacy, safety and tolerability of VK5211 in patients recovering from hip fracture surgery. The top-line data from this study showed that the trial successfully achieved its primary efficacy endpoint, demonstrating statistically significant, dose dependent increases in lean body mass and less head, among patients treated with VK5211, as compared to placebo. The study also achieved important secondary endpoints, demonstrating statistically significant improvements in appendicular lean body mass and total lean body mass compared to placebo. Patients receiving VK5211 also demonstrated numerical improvements in certain exploratory assessments of functional performance. VK5211 demonstrated encouraging safety and tolerability, with no drug-related serious adverse events reported in this study.
Ironwood Pharmaceuticals Initiates Phase IIIb Study of Linaclotide for Irritable Bowel Syndrome
Ironwood Pharmaceuticals announced the initiation of a Phase IIIb clinical trial evaluating the efficacy and safety of linaclotide 290 mcg on multiple abdominal symptoms in addition to pain, including bloating and discomfort, in adult patients with irritable bowel syndrome with constipation (IBS-C). The randomized, double-blind, placebo-controlled, parallel-group study aims to enroll approximately 600 adult IBS-C patients in the United States. Eligible patients will be randomized to placebo or linaclotide 290 mcg once daily for 12 weeks, followed by a four-week randomized withdrawal period. The primary efficacy endpoint is a change from baseline in abdominal score based on daily patient assessments of abdominal bloating, discomfort, and pain at their worst, as reported on an 11-point numerical rating scale. Additional endpoints include change from baseline in spontaneous bowel movement (SBM) frequency, complete spontaneous bowel movement (CSBM) frequency, stool consistency and straining.
Pfizer and Lilly Announce Positive Top-Line Results from Phase III Trial
Pfizer and Eli Lilly and Company announced that a 16-week Phase III study in patients with osteoarthritis (OA) pain evaluating subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints. The study demonstrated that patients who received two doses of tanezumab separated by eight weeks experienced a statistically significant improvement in pain, physical function and the patients’ overall assessment of their OA, compared to those receiving placebo. Preliminary safety data showed that tanezumab was generally well tolerated, with approximately 1 percent of patients discontinuing treatment due to adverse events. Rapidly progressive osteoarthritis was observed in tanezumab-treated patients at a frequency of less than 1.5 percent, and was not observed in the placebo arm. The Phase III OA study (A4091056) was a 16-week randomized, double-blind, placebo-controlled, multicenter, parallel-group trial evaluating the efficacy and safety of subcutaneous administration of tanezumab compared to placebo in patients with OA of the knee or hip. The trial included a 24-week safety follow-up period. In the study, patients were enrolled with moderate to severe OA pain who had experienced inadequate pain relief with other treatment options for OA pain or were unable to take other pain medications. A total of 698 patients were randomized to three treatment groups in a 1:1:1 ratio to receive two injections over the 16-week study, once every eight weeks. One group received two doses of placebo, the second group received two doses of tanezumab 2.5 mg, and the third group received one dose of tanezumab 2.5 mg followed by one dose of tanezumab 5 mg eight weeks later. The efficacy of tanezumab vs. placebo was measured by changes from baseline at 16 weeks.
Phase III Data Show Vedolizumab Meets Primary Endpoint
Takeda Pharmaceutical Company Limited announced top-line results from the VISIBLE 1 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of vedolizumab for maintenance therapy in adult patients with moderately to severely active ulcerative colitis (UC)/ VISIBLE 1 is a pivotal Phase III, randomized, double-dummy, double-blind, placebo-controlled study with a vedolizumab IV reference arm, to evaluate the safety and efficacy of an investigational SC formulation of vedolizumab for adult patients with moderately to severely active UC who have achieved clinical response at week six following two doses of open-label vedolizumab IV therapy at weeks zero and two.The study enrolled 384 patients, all of whom had inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators or tumor necrosis factor-alpha (TNFα)-antagonist therapy prior to being enrolled. Patients who achieved clinical response at week six were randomized into one of three treatment groups, vedolizumab SC 108 mg and placebo IV, vedolizumab IV 300 mg and placebo SC or placebo SC and placebo IV. In the primary endpoint of the trial, a statistically significant proportion of patients receiving vedolizumab SC beginning at week six and every two weeks following achieved clinical remission at week 52 compared to placebo. The safety data were consistent with the known safety profile of vedolizumab, and no new safety signals were identified.