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...Based on the top-line analysis and other
Repros Therapeutics Inc., of The Woodlands, Texas, reported top-line Phase II data showing Androxal significantly increased testosterone levels at both the low and high doses vs
Furiex Pharmaceuticals Inc., of Morrisville, N.C., said top-line results from a Phase II trial of PPD-10558 in patients with statin-associated myalgia (SAM) did not meet its primary efficacy endpoint...Gilead Sciences Inc., of Foster City, Calif., said top-line Phase III results showed that elvitegravir, an integrase inhibitor in development for HIV, was noninferior to the integrase inhibitor raltegravir after two years of therapy in treatment-experienced patients
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
Adeona Pharmaceuticals Inc., of Ann Arbor, Mich., said its collaborator, the PNA Center for Neurological Research, reported top-line results from a pilot Phase I/II study in amyotrophic lateral sclerosis (ALS) patients, which showed no safety issues related to zinc therapy
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
Theravance Inc., of South San Francisco, reported positive top-line results from a Phase IIa single-dose study of TD-4208, its inhaled long-acting muscarinic antagonist for chronic obstructive pulmonary disease
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
Sinovac Biotech Ltd., of Beijing, reported that its vaccine for hand, foot and mouth disease (HFMD) showed positive top-line results in a Phase II trial
NeurogesX Inc., of San Mateo, Calif., reported top-line data from a Phase II study of NGX-1998, a topical liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia, showing that the trial met its primary endpoint of a percentage change from baseline vs
Biogen Idec, of Weston, Mass., reported positive top-line results from CONFIRM, the second of two pivotal Phase III trials designed to evaluate the investigational oral compound BG-12 (dimethyl fumarate) in relapsing-remitting multiple sclerosis (RRMS...Dynavax reported top-line Phase III data on Heplisav in July. (See BioWorld Today, July 21, 2011
Galderma Pharma SA, of Lausanne, Switzerland, reported top-line results from a Phase IIb trial showing that CD07805/47, a topical gel in development for moderate to severe facial erythema of rosacea, was rapidly effective at reducing facial redness...Top-line data are anticipated by year-end
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...Based on the top-line analysis and other