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
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
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
Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase IIb study testing Stelara (ustekinumab) in moderate to severe Crohn's disease showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, defined as a 100-point reduction in Crohn's Disease Activity Index
Abbott, of Abbott Park, Ill., said initial results from its Phase IIb study of its interferon-free regimen for hepatitis C virus (HCV) showed sustained virological response at 12 weeks post-treatment in 99 percent of treatment-naïve and 93 percent of null responder patients with genotype I HCV
Euthymics Bioscience Inc., of Cambridge, Mass., completed enrollment in the Phase IIb/IIIa study of its lead product candidate amitifadine (formerly called EB-1010), a serotonin-preferring triple reuptake inhibitor for the treatment of major depressive disorder (MDD...Grupo Zeltia, of Madrid, Spain, said its subsidiary Noscira, which is focused on developing treatments for neurodegenerative diseases, disclosed that the primary cognitive endpoint and two of the secondary endpoints were not met in
BioLineRx Ltd., of Jerusalem, said a recent analysis of data from its Phase IIb EAGLE trial testing orally available GABA-enhanced antipsychotic BL-1020 in schizophrenia indicated that the drug demonstrated a significant increase in efficacy at improving cognitive impairment associated with the condition, as compared to the original analysis of the study...Sophiris Bio Inc., of La Jolla, Calif., released top-line data from the 12-month follow-up of patients receiving PRX302 for the treatment of
GTx Inc., of Memphis, Tenn., said it will present data later this month at the International Society of Geriatric Oncology meeting in Manchester, UK, from its Phase IIb trial of enobosarm improved physical function in cancer patients with muscle wasting...Sangart Inc., of San Diego, said it completed patient enrollment in its Phase IIb study designed to test MP4OX treatment in severely injured trauma patients experiencing hemorrhagic shock
The Medicines Co., of Parsippany, N.J., said it voluntarily discontinued its Phase IIb dose-ranging study of MDCO-2010, a serine protease inhibitor that was in development to reduce blood loss during surgery
Inc., of Whitehouse Station, N.J., said Phase IIb data showed that MK-3102, its once-weekly DPP-4 inhibitor for Type II diabetes, significantly lowered blood sugar in the 12-week study, compared to placebo, with an incidence of symptomatic hypoglycemia that was similar to placebo
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