Esperion Therapeutics Inc., of Plymouth, Mich., reported top-line results from a Phase IIa trial of ETC-1002 for hypercholesterolemia in patients with a history of intolerance to two or more statins
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., disclosed positive top-line results for Eylea (aflibercept) Injection from the Phase III MYRROR study in myopic choroidal neovascularization
Euthymics Bioscience Inc., of Cambridge, Mass., reported top-line results from TRIADE (Triple Reuptake Inhibitor Anti-Depressant Effects), a Phase IIb/IIIa study designed to assess the safety and efficacy of amitifadine, a serotonin-preferring triple reuptake inhibitor antidepressant, in patients with major depressive disorder (MDD) failing to respond to one course of first-line antidepressants
Novo Nordisk A/S, of Bagsvaerd, Denmark, reported top-line results from a 56-week Phase IIIa trial testing the potential of GLP-1 drug liraglutide to induce and maintain weight loss in people without diabetes who are obese or overweight with co-morbidities such as prediabetes, hypertension and dyslipidemia
The company expects to report top-line results from the current study in late 2013 or early 2014 and to file a new drug application with the FDA in 2014. (See BioWorld Today, March 20, 2013
Civitas Therapeutics Inc., of Chelsea, Mass., disclosed positive top-line results from a Phase II trial of CVT-301, an inhaled formulation of levodopa (L-dopa
Collegium Pharmaceutical Inc., of Canton, Mass., said top-line results from a Phase I trial of Oxycodone DETERx, its extended-release, abuse-deterrent multiparticulate product in a capsule form, showed that both the crushed and chewed content of DETERx capsules were bioequivalent to intact DETERx capsules in the fed state, demonstrating that crushing or chewing the contents does not alter the pharmacokinetics
GlycoMimetics Inc., of Gaithersburg, Md., reported top-line results from a Phase II study showing that patients with vaso-occlusive crisis of sickle cell disease who were treated with GMI-1070 experienced reduction in duration of vaso-occlusive crisis, reduction in length of hospital stay and reduction in the use of narcotic pain relief
Almirall SA, of Barcelona, Spain, and Forest Laboratories Inc., of New York, reported top-line results from a six-month pivotal Phase III study testing fixed-dose combinations of aclidinium bromide, a long-acting muscarinic beta2 agonist, and formoterol fumarate, a long-acting beta2 agonist, delivered using Almirall's inhaler Genuair
Reviva Pharmaceuticals Inc., of San Jose, Calif., reported top-line results from its Phase II REFRESH study of RP5063 in schizophrenia and schizoaffective disorder, with the dopamine serotonin stabilizer showing overall broad efficacy across the Positive and Negative Syndrome Scale total scores, as well as subscales: Positive, Negative and General Psychopathology
Navidea Biopharmaceuticals Inc., of Dublin, Ohio, disclosed top-line results from the interim analysis of its Phase III trial, NEO3-06, of the imaging agent Lymphoseek for injection in patients with head and neck squamous cell carcinoma
Trius Therapeutics Inc., of San Diego, reported top-line results from its ESTABLISH 2 Phase III study of tedizolid phosphate (TR-701) in acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA
and Europe, with top-line results due in the second half of 2013...MethylGene Inc., of Montreal, reported top-line results from a trial of MGCD290 in combination with fluconazole for vulvovaginal candidiasis
Concert expects to report top-line results by the end of 2013