Gilead, which reported top-line data from Study 102 in August 2011, submitted a new drug application for Quad late last year. (See BioWorld Today, Aug. 16, 2011
Assuming its clinical trial application is granted, top-line data would be available in the third quarter, with a Phase II data in DMD patients starting in the first half of 2013
Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, disclosed top-line data from the GetGoal-P Phase III study, showing lixisenatide, a once-daily glucagon-like peptide 1 agonist, hit its primary efficacy endpoint of significantly reducing blood glucose levels compared to placebo (p < 0.0001), with HbA1c decreasing from a mean baseline value of 8.08 percent to a mean value of 7.06 percent after 24 weeks in the lixisenatide group and from 8.05 percent to 7.59 percent in
The company previously reported top-line data showing that combining its investigational purine nucleoside phosphorylate inhibitor, BCX4208, with a 300-mg dose of allopurinol could double the number of patients who achieve normal sUA levels. (See BioWorld Today, Oct. 6, 2011
Civitas Therapeutics Inc., of Chelsea, Mass., reported top-line data from a Phase I healthy volunteer trial of CVT-301, an inhaled formulation of levodopa (L-dopa) in development for the rapid relief from motor fluctuations associated with Parkinson's disease...Durect Corp., of Cupertino, Calif., said top-line data from its Phase III BESST (Bupivacaine Effectiveness and Safety in SABER) study of Posidur in postoperative pain relief failed to reach statistical significance, though results trended
Rib-X Pharmaceuticals Inc., of New Haven, Conn., reported top-line data from its Phase IIb study of antibiotic delafloxacin for acute bacterial skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus, indicating that delafloxacin met or exceeded primary and secondary efficacy endpoints when compared to Zyvox (linezolid, Pfizer Inc.), with and without aztreonam, and vancomycin, with and without aztreonam
The companies expect to report top-line data during the first quarter of 2012 and to complete enrollment and report data from the second Phase III, ULISES 008, during the first half of next year
ViroPharma Inc., of Exton, Pa., and Halozyme Therapeutics Inc., of San Diego, reported top-line data from an open-label Phase II trial of a subcutaneous version of hereditary angioedema drug Cinryze (C1 esterase inhibitor), showing that the addition of Halozyme's Enhanze delivery technology, which uses recombinant human hyaluronidase enzyme, led to maximum levels and greater systemic exposure of functional and antigenic C1 inhibitor for both doses tested as compared to subcutaneous
Top-line data showed that, at the end of the open-label phase, mean daily "off time" was reduced from baseline by 2.0 hours for Sinemet compared to 3.4 hours for 279/CD
GlaxoSmithKline plc, of London, said top-line data from the first of eight Phase III studies of albiglutide, a once-weekly glucagon-like peptide-1 agonist, failed to meet the primary endpoint of noninferiority to Victoza (liraglutide, Novo Nordisk A/S), though it did demonstrate a statistically significant reduction in HbA1c from baseline (p < 0.001...Nile Therapeutics Inc., of San Mateo, Calif., released top-line data from a Phase I trial of cenderitide in chronic heart failure
The second Phase III trial is expected to complete enrollment by the end of the year, with top-line data from the first trial anticipated around the end of 2012
Provectus Pharmaceuticals Inc., of Knoxville, Tenn., reported top-line data for its Phase II trial of PH-10 in mild to moderate plaque psoriasis