Top-line results are expected in the second half of this year

Forest Laboratories Inc., of New York, reported top-line results from two Phase III trials of cariprazine (RGH-188) in acute exacerbation of schizophrenia, showing that patients treated with the dopamine D3-preferring D3/D2 receptor partial agonist experienced significant symptom improvement compared to the placebo group, as measured by the Positive And Negative Syndrome Scale, the primary endpoint in both studies

Ltd., of Osaka, Japan, reported top-line results from the GEMINI I Phase III study of vedolizumab in 895 patients with moderately to severely active ulcerative colitis who have failed at least one conventional therapy, including tumor necrosis factor-alpha antagonists

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

Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., reported top-line response data from its randomized, multicenter, Phase II trial of oral sapacitabine, a nucleoside analogue, in older patients with myelodysplastic syndromes (MDS) after treatment failure of hypomethylating agents, such as azacitidine and/or decitabine

Forest Laboratories Inc., of New York, and Gedeon Richter plc, of Budapest, Hungary, reported top-line results from a Phase III trial of cariprazine (RHG-188), an antipsychotic agent, in patients with acute mania associated with bipolar I disorder...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

Inc., of Whitehouse Station, N.J., reported top-line results from the TRA-2P (Thrombin Receptor Antagonist in Secondary Prevention of atherothrombotic ischemic events) study of vorapaxar, showing the drug, an oral protease activated receptor 1 thrombin receptor angonist, met the primary endpoint in preventing clot formation and reducing cardiovascular events

Top-line results are expected at the end of the fourth quarter of 2012

The company expects to complete the Phase III and release top-line data in mid-2012

Infinity has completed enrollment in the Phase II portion of the study, with top-line data anticipated in the second half of this year

Prolor Biotech Inc., of Nes-Ziona, Israel, reported top-line results from a post-Phase II study of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in growth hormone-deficient adults, showing that two injections of hGH-CTP per month have the potential to replace 30 consecutive daily injections of currently marketed human growth hormone

Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, reported top-line results from the first study testing the combined effects of LX4211 , a sodium glucose transporter 1 and 2 inhibitor, with DPP-4 inhibitor Januvia (sitagliptin, Merck & Co. Inc.), showing that the combination produced lower blood glucose levels after meals compared to sitagliptin alone (p = 0.012

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

Alkermes plc, of Dublin, Ireland, reported top-line results from a 32-patient Phase I/II study, showing that ALKS 5461 was able to significantly reduce depressive symptoms in subjects with major depressive disorder (MDD), as measured by the Hamilton Depression Rating Scale

Top-line data from the first Phase III study is expected around the end of 2012 and from the second Phase III in early 2013...Repros Therapeutics Inc., of The Woodlands, Texas, provided top-line results for the end-of-dosing analysis of its ZA-203 Phase IIb study of Androxal in secondary hypogonadal men with moderate to severe dysfunction

Top-line results from Genzyme Corp.'s Phase III (TENERE) trial of oral teriflunomide compared to interferon beta 1a (Rebif) for multiple sclerosis showed no statistical superiority on its primary composite endpoint, risk of treatment failure

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