Merck & Co. Inc., of Whitehouse Station, N.J., reported data from two pivotal Phase III trials of suvorexant in insomnia at SLEEP 2012, the annual Meeting of the Associated Professional Sleep Societies. The orexin receptor antagonist reduced the time it took patients to fall asleep and increased the time that patients stayed asleep as early as the first night and at three months, compared to placebo. Endpoints from the trials included mean change from baseline for suvorexant compared to placebo
Eli Lilly and Co., of Indianapolis, and Boehringer Ingelheim GmbH, of Ingelheim, Germany, presented results from two Phase II studies of their investigational basal insulin analogue LY2605541 at the American Diabetes Association meeting in Philadelphia. In a Type I diabetes trial, patients treated with LY2605541 showed better glycemic control after eight weeks than those who received insulin glargine. The LY2605541 patients also had a 17 percent reduction in their mealtime insulin dose while
Grifols SA, of Barcelona, Spain, said Phase I data published in the Journal of Thrombosis and Haemostasis demonstrated good safety and tolerability for investigational therapy plasmin in treating patients with acute peripheral atrial occlusion. While the 83-patient study was not powered for efficacy, the data demonstrated that thrombolysis (greater than or equal to 50 percent) occurred in 79 percent of subjects receiving 125 mg to 175 mg of plasmin, compared to 50 percent who received 25 mg to
UCB SA, of Brussels, Belgium, reported data from a post-hoc analysis of the Phase IIIb REALISTIC (RA Evaluation in Subjects Receiving TNF Inhibitor Certolizumab Pegol) study, showing that, overall, 81.1 percent of rheumatoid arthritis patients treated with Cimzia (certolizumab pegol) during both the 12-week and open-label extension had a change in DAS28 equal to or greater than 1.2 and 89.3 percent had at least a 29 percent change in swollen joint count from baseline by week 12. Data were
Otsuka Pharmaceutical Co. Ltd., of Tokyo, said Phase IIb safety and efficacy data for delamanid, its investigational compound in multidrug-resistant tuberculosis (MDR-TB) were published in the New England Journal of Medicine. Results from the trial showed a 53 percent increase in sputum culture conversion (SCC) after two months for subjects who received delamanid 100 mg twice daily plus a background regimen (BR) consistent with World Health Organization treatment guidelines, compared with
Janssen Research & Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, reported data from the Phase III PHOENIX study showing that maintenance treatment with Stelara (ustekinumab) for up to five years resulted in consistent, significant clinical response in adults with moderate to severe plaque psoriasis. Among responders receiving Stelara 45 mg or 90 mg and randomized to continue maintenance therapy through five years, 79 percent and 81 percent, respectively, experienced at
Bristol-Myers Squibb Co., of New York, reported four-year results from the long-term extensions of the BENEFIT and BENEFIT-EXT trials evaluating Nulojix (belatacept), its selective T-cell co-stimulation blocker indicated for the prophylaxis of organ rejection in adult Epstein-Barr virus-seropositive patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids. Results showed that the safety profile of the drug through year four was
Eli Lilly and Co., of Indianapolis, and Kowa Pharmaceuticals America Inc., of Montgomery, Ala., reported results from the PREVAIL (Pitavastatin compaREd with praVAstatin in Lowering LDL-C in the U.S.) study, which showed that Livalo (pitavastatin) 4 mg had superior LDL-C reduction compared with pravastatin 40 mg after 12 weeks of therapy. Data for secondary endpoints showed that Livalo reduced apoliprotein B, non-HDL-C and total cholesterol compared with pravastatin and improved high-density
Pfizer Inc., of New York, said the European Medicines Agency's Committee for Human Medicinal Products recommended marketing authorization for axitinib as a second-line treatment for adults with advanced renal cell carcinoma. The oral kinase inhibitor was approved in January in the U.S., where it is marketed as Inlyta.
Summit Corp. plc, of Oxford, UK, dosed the first cohort of patients in a Phase I study of SMT C1100, a small-molecule utrophin up-regulator under investigation in Duchenne's muscular dystrophy (DMD). The dose-escalating trial, supported by $1.5 million from a group of U.S.-based DMD organizations, will evaluate an aqueous formulation of SMT C1100 in healthy volunteers to see if it can provide the consistent levels of drug in the blood that nonclinical efficacy studies predicted would be
Boehringer Ingelheim Pharmaceuticals Inc., of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, reported Phase III results for Tradjenta (linagliptin) 5 mg once-daily, which showed significant hemoglobin A1c reduction of 0.88 percent compared with 0.24 percent in the placebo group at 24 weeks. The trial was the first published study of a DPP-4 inhibitor specifically conducted in African American adults with Type 2 diabetes. The data were presented at the American Association of
Shire plc, of Dublin, Ireland, reported Phase III results demonstrating the long-term maintenance efficacy of lisdexamfetamine dimesylate (LDX) in children and adolescents, ages 6 to 17, with attention deficit hyperactivity disorder (ADHD). A significantly lower proportion of ADHD treatment failures (13.5 percent) were seen in the LDX group, compared to placebo (65.8 percent), and the majority of placebo-treated subjects who met protocol-defined ADHD symptom relapse criteria did so within two
Achillion Pharmaceuticals Inc., of New Haven, Conn., reported proof-of-concept data from a Phase Ib trial demonstrating that patients with chronic hepatitis C virus (HCV) genotype 1 treated with ACH-2684, a second-generation protease inhibitor, achieved a mean maximum 3.73 log10 reduction in HCV RNA after three-day 400-mg monotherapy with once-daily dosing. The compound also demonstrated good safety and tolerability in healthy volunteers and in patients with HCV. AltheRx Pharmaceuticals Inc
Avraham Pharmaceuticals Ltd., of Yavne, Israel, initiated a Phase II trial to evaluate the safety and efficacy of ladostigil in mild cognitive impairment (MCI). The 36-month randomized, multicenter, double-blind, placebo-controlled trial will include at least 200 patients in 16 centers in Europe and Israel. In parallel, Avraham completed the enrollment of 200 patients in an ongoing Phase II study of ladostigil in mild to moderate Alzheimer's disease (AD). The double-blind, closed-label, placebo
Cytochroma Ltd., of Markham, Ontario, reported data from a 78-subject Phase IIb trial showing that CTAP101 capsules effectively and safely lowered elevated plasma intact parathyroid hormone (iPTH) in patients with Stage III or Stage IV chronic kidney disease and vitamin D insufficiency. The drug increased serum total 25-hydroxyvitamin D (25D) and reduced plasma iPTH significantly, in a dose-proportional manner compared to placebo. Low serum total 25D was corrected to adequate levels (less than
H. Lundbeck A/S, of Copenhagen, Denmark, and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, reported data showing significant improvements in overall symptoms of depression in elderly patients taking Lu AA21004, with patients taking 5 mg of the multimodal depression drug showing a significantly greater (p = 0.0011) improvement on the primary efficacy endpoint of HAM-D24 total score vs. placebo at week eight. Rates of HAM-D24 response were 53.2 percent vs. 35.2 percent, and rates of HAM-D17
Dainippon Sumitomo Pharma Co. Ltd., of Osaka, Japan, said Latuda (lurasidone HCL) met its key primary and secondary endpoints in two Phase III trials in bipolar I depression. The trials were designed to evaluate safety and efficacy of Latuda as adjunct therapy (PREVAIL 1) and monotherapy (PREVAIL 2). In both studies, patients achieved statistically significant improvements in symptoms of depression, according to the Montgomery-Asberg Depression Rating Scale, compared to placebo. Galleon
Sanofi SA, of Paris, said vaccine division Sanofi Pasteur reported Phase III data from a pediatric study of quadrivalent influenza vaccine (QIV) in children 6 months through 8 years of age, with results supporting results in prior studies in adults. The noninferiority comparisons also demonstrated that the addition of a fourth influenza strain to the investigational vaccine does not adversely affect the safety and immunogenicity profiles of QIV compared to those of Sanofi's licensed vaccine
Savara Pharmaceuticals, of Austin, Texas, reported top-line data from its Phase Ia study of AeroVanc, an inhaled antibiotic. AeroVanc (vancomycin hydrochloride inhalation powder) is a dry powder form of vancomycin in a capsule-based inhaler to treat respiratory methicillin-resistant Staphylococcus aureus infections in patients with cystic fibrosis (CF). The dose-escalating Phase Ia trial examined the safety and pharmacokinetics of AeroVanc in healthy volunteers. Single-ascending doses of
Cytokinetics Inc., of South San Francisco, reported data on two Phase II trials evaluating CK-2017357, the lead candidate in its skeletal muscle contractility program, in patients with amyotrophic lateral sclerosis (ALS) at the American Academy of Neurology annual meeting in New Orleans. The trials evaluated the multi-week safety and tolerability of different doses and dosing schedules of CK-2017357, with and without riluzole (Rilutek, Sanofi SA), the only approved treatment for ALS. Consistent
Merck & Co. Inc., of Whitehouse Station, N.J., reported data from two pivotal Phase III trials of suvorexant in insomnia at SLEEP 2012, the annual Meeting of the Associated Professional Sleep Societies. The orexin receptor antagonist reduced the time it took patients to fall asleep and increased the time that patients stayed asleep as early as the first night and at three months, compared to placebo. Endpoints from the trials included mean change from baseline for suvorexant compared to placebo