Latest New Medical Therapy Trial Results

Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results are also searchable by therapeutic area beginning with the most recent updates.

Week of 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 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% 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% and 94.8% for eravacycline (n=363/428) and ertapenem (n=382/403), respectively (-10% CI: -14.1%, -6.0%). Responder rates at the TOC visit were 68.5% and 74.9% for eravacycline (n=293/428) and ertapenem (n=302/403), respectively (-6.5% CI: -12.6%, -0.3%).

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.





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