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Trial Results

Eli Lilly Announces Positive Results for Ankylosing Spondylitis

February 19, 2018

Eli Lilly announced that Taltz (ixekizumab) met the primary and all key secondary endpoints in COAST-V, a Phase II study evaluating the safety and efficacy of Taltz for the treatment of ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (axSpA). COAST-V is a multicenter, randomized, double-blind, active and placebo-controlled 16-week study. The trial included a placebo arm and an active control arm (adalimumab) for comparison with placebo, and studied patients who had never received a biologic disease-modifying anti-rheumatic drug (bDMARD). Taltz demonstrated a statistically significant improvement in the signs and symptoms of AS. Patients were required to have an established diagnosis of AS with active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Numeric Rating Scale (NRS) score ≥4 and a total back pain NRS score ≥4. During the study, ixekizumab-treated patients received a starting dose of 80mg or 160mg, followed by one of two dosing regimens: either 80mg administered subcutaneously once every two weeks or 80mg administered subcutaneously once every four weeks. The COAST-V study will also evaluate the long-term efficacy and safety of ixekizumab in patients with AS up to one year.

Tetraphase’s Lead Antibiotic Fails Another Late-Stage Study
Tetraphase Pharmaceuticals announced that its IGNITE3 clinical trial evaluating the efficacy and safety of once-daily intravenous (IV) eravacycline compared to ertapenem for the treatment of patients with complicated urinary tract infections (cUTI) did not achieve statistical non-inferiority of eravacycline to ertapenem. The study failed to meet the co-primary efficacy endpoints of responder rate in the microbiological intent-to-treat (micro-ITT) population at the end-of-IV (EOI) treatment visit and at the test-of-cure (TOC) visit, which were evaluated using a 10 percent non-inferiority margin. Eravacycline was well-tolerated in IGNITE3, with a safety profile consistent with prior studies. IGNITE3 was a Phase III randomized, multicenter, double-blind clinical trial evaluating the efficacy and safety of once-daily IV eravacycline. The Phase III IGNITE3 clinical trial enrolled 1,205 patients who were randomized 1:1 for a minimum of five days, and then were eligible for transition to an appropriate approved oral agent. Responder rates in the micro-ITT population at the EOI visit were 84.8 percent and 94.8 percent for eravacycline (n=363/428) and ertapenem (n=382/403), respectively (-10 percent CI: -14.1 percent, -6.0 percent). Responder rates at the TOC visit were 68.5 percent and 74.9 percent for eravacycline (n=293/428) and ertapenem (n=302/403), respectively (-6.5 percent CI: -12.6 percent, -0.3 percent).

Vertex’s NaV1.8 Inhibitor VX-150 Showed Significant Acute Pain Relief
Vertex Pharmaceuticals announced positive results of a Phase II study of the NaV1.8 inhibitor VX-150 in patients with acute pain following bunionectomy surgery. Treatment with VX-150 showed statistically significant relief of acute pain compared to placebo, as determined by the time-weighted Sum of the Pain Intensity Difference over the first 24 hours of treatment (SPID24). The study also included a standard-of-care reference arm of the commonly prescribed opioid medicine hydrocodone+acetaminophen to support the evaluation of a potential treatment effect for VX-150. VX-150 was generally well-tolerated, and there were no discontinuations for adverse events in any arm of the study. This Phase II study is the second positive proof-of-concept study for VX-150 and provides further validation for the use of a NaV1.8 inhibitor for the treatment of pain. The data announced were from a Phase II randomized, double-blind, placebo-controlled study that evaluated two days of treatment with VX-150, hydrocodone+acetaminophen or placebo in 243 patients with acute pain following bunionectomy surgery. Eighty-two patients received placebo, 80 patients received VX-150 and 81 patients received hydrocodone+acetaminophen. Hydrocodone+acetaminophen (5mg+325mg q6h) was included as a standard-of-care reference arm to enable better evaluation of a potential treatment effect for VX-150. The reference arm was not included to make statistical comparisons to VX-150. VX-150 was dosed orally as 1500 mg for the first dose, followed by 750mg every 12 hours over the 48-hour treatment period. VX-150 was generally well-tolerated, and there were no discontinuations for adverse events in any arm of the study.