Synergy Pharmaceuticals Inc., of New York, said plecanatide, its oral guanylate cyclase C agonist for chronic idiopathic constipation, was well tolerated and met the primary and key secondary endpoints in a Phase IIb/III study

Synergy Pharmaceuticals Inc., of New York, said dosing has commenced in a Phase IIb trial of plecanatide to treat patients with constipation-predominant irritable bowel syndrome (IBS-C

Neurocrine Biosciences Inc., of San Diego, said it started a Phase IIb trial (Kinect 2 Study) of its vesicular monoamine transporter 2 compound, NBI-98854...ViroPharma Inc., of Exton, Pa., and Halozyme Therapeutics Inc., of San Diego, said ViroPharma started a Phase IIb dose-ranging study to test subcutaneous administration of Cinryze (C1 esterase inhibitor [human]) in combination with Halozyme's Enhanze technology, which uses recombinant human hyaluronidase enzyme

Pharmalink AB, of Stockholm, Sweden, began a Phase IIb trial of Nefecon (Nefigan) for IgA nephropathy

Celladon Corp., of San Diego, dosed its first patient in Europe in a Phase IIb trial of Mydicar for heart failure

Biotie Therapies Corp., of Turku, Finland, reported top-line data from a Phase IIb study showing that tozadenant (SYN115), its adenosine A2a antagonist, met the primary endpoint of decreasing the "off" time in Parkinson's patients experiencing levodopa-related end-of-dose wearing off vs

Sarepta Therapeutics Inc., of Cambridge, Mass., said updated data from Study 202, its open-label, Phase IIb extension study of eteplirsen for the treatment of Duchenne's muscular dystrophy, showed that patients treated with eteplirsen for 62 weeks and evaluable on ambulatory measures (modified intent-to-treat population) maintained a statistically significant clinical benefit on the primary clinical outcome measure, the six-minute walk test, compared to patients who received placebo for 24 weeks

Cytokinetics Inc., of South San Francisco, opened enrollment of the third and final cohort in its ATOMIC-AHF Phase IIb trial of omecamtiv mecarbil in left ventricular systolic dysfunction in patients hospitalized for heart failure

Anthera Pharmaceuticals Inc., of Hayward, Calif., reported additional data from its Phase IIb PEARL-SC study at the Asian Lupus Summit meeting in Manila, Philippines, related to the effect of blisibimod on renal disease in lupus

Genfit SA, of Lille, France, said the first patients have been recruited in its pivotal Phase IIb study testing GFT505 in nonalcoholic steatohepatitis (NASH...Oxygen Biotherapeutics Inc., of Morrisville, N.C., said it is partnering with contract research organization (CRO) Pharmaceutical Product Development LLC to resume and complete the firm's Phase IIb STOP-TBI (Safety and Tolerability of Oxycyte in Patients with Severe non-Penetrating Traumatic Brain Injury) trial

That agreement will allow the university to proceed with two National Institutes of Health-funded Phase IIb trials, totaling about $10 million

Anthera Pharmaceuticals Inc., of Hayward, Calif., said an abstract describing results from the Phase IIb PEARL-SC study of blisibimod in systemic lupus erythematosus was accepted as a late-breaking poster presentation at the American College of Rheumatology meeting in Washington

Edison Pharmaceuticals Inc., of Mountain View, Calif., said it started a Phase IIb study testing EPI-743 in children with Leigh syndrome, an inherited lethal and progressive neuromuscular disease...The Abili-T trial, a Phase IIb study of Tcelna (imilecleucel-T) in SPMS, is expected to enroll 180 patients at approximately 30 sites in the U.S

Intercept Pharmaceuticals Inc., of New York, completed patient enrollment in the FLINT Phase IIb trial of obeticholic acid (OCA) for adult nonalcoholic steatohepatitis

Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, said Phase IIb data presented at the American Heart Association meeting in Los Angeles showed that LX4211, an oral, dual inhibitor of sodium glucose co-transporters (SGLT) 1 and 2, produced maximal 24-hour urinary glucose excretion at 200 mg, whereas maximal HbA1c reduction was obtained at the 400-mg dose...Last month, Synta disclosed positive findings from an interim analysis of the Phase IIb portion of GALAXY. (See BioWorld Today, Oct. 2

The product was well tolerated, with no serious side effects reported, and Aerie said it plans to advance into Phase IIb testing

EnVivo Pharmaceuticals Inc., of Watertown, Mass., said data from its Phase IIb study of EVP-6124, an alpha-7 agonist, in Alzheimer's disease met both of the trial's primary endpoints, with statistically significant positive effects on cognition (p = 0.0189), as measured by ADAS-COG-13, and clinical function (p = 0.0253), as measured by the Clinical Dementia Rating Scale Sum of Boxes

Cytokinetics Inc., of South San Francisco, said it opened its Phase IIb BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS) testing tirasemtiv, formerly CK-2017357, in patients with amyotrophic lateral sclerosis (ALS

The firm reported a reanalysis of the Phase IIb EAGLE study earlier this month showing that, BL-1020 is even more potent in improving cognitive function when data take into account effects of the circadian rhythm on cognitive function...Pearl Therapeutics Inc., of Redwood City, Calif., said it completed its dose-ranging Phase IIb trial of PT003, its inhaled combination bronchodilator product for moderate to severe chronic obstructive pulmonary disease