Abbvie Inc., of Chicago, reported positive results from its pivotal phase III study, PEARL-III, at the 21st Conference on Retroviruses and Opportunistic Infections. PEARL-III evaluated the efficacy and safety of 12 weeks of treatment with Abbvie’s investigational therapy with or without ribavirin (RBV) in non-cirrhotic, adult patients with chronic genotype 1b (GT1b) hepatitis C virus (HCV) infection who were new to treatment. The PEARL-III study met its primary and secondary endpoints. In the 419-patient study, sustained virologic response rates 12 weeks post-treatment (SVR12) of 99.5 and 99 percent were achieved with the Abbvie regimen with and without RBV, respectively. There were no study drug discontinuations due to adverse events. The investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) with or without RBV (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the HCV replication process with the goal of optimizing SVR rates across different patient populations.

Array Biopharma Inc., of Boulder, Colo., reported full results from a randomized phase II trial of ARRY-502 in patients with mild to moderate Th2-driven asthma at the American Academy of Allergy, Asthma & Immunology Annual Meeting in San Diego. The placebo-controlled, randomized, double-blind trial of the oral CRTh2 antagonist, which enrolled 184 patients, met the primary endpoint, showing improved pre-bronchodilator Forced Expiratory Volume in one second (FEV1), by 3.9 percent compared to placebo, achieving statistical significance (p = 0.02). FEV1 responses for the total cohort also were statistically significant on a week-by-week basis. A predefined endpoint using the median baseline value of fractional exhaled nitric oxide, or FENO, a Th2 associated biomarker, was also evaluated. Patients with elevated baseline FENO demonstrated enhanced activity, with a median FEV1 improvement of 6.8 percent compared to placebo at week four (p = 0.008). Secondary efficacy endpoints also achieved statistical significance, including reduced short-acting beta agonist use, improved asthma control, forced vital capacity improvement and improvement in Rhinasthma and Asthma Quality of Life questionnaires. Overall, ARRY-502 was well tolerated, with fewer adverse events in the ARRY-502 group than in the placebo group, including fewer asthma exacerbations. The company said it is seeking a partner to advance ARRY-502 through development.

Arrowhead Research Corp., of Pasadena, Calif., said it received regulatory approval to begin a phase IIa trial of ARC-520, its RNAi-based drug candidate for the treatment of chronic hepatitis B virus infection, from the Hong Kong Department of Health. The planned single-dose study will involve two cohorts at two dose levels. The primary objective is to evaluate the depth and duration of HBsAG decline in response to a single dose of ARFC-520 in combination with Baraclude (entecavir, Bristol-Myers Squibb Co.), while secondary objectives include evaluation of safety and tolerability and pharmacokinetic measures. The company expects top-line results to be available in the third quarter.

Atopix Therapeutics Ltd., of Abingdon, UK, said results from a phase IIb asthma study testing OC459, a CRTH2 antagonist, demonstrated that the drug, when dosed at 25 mg once daily, statistically significantly improved lung function vs. placebo. Treatment with OC459 also led to a statistically significant reduction in the incidence of respiratory tract infections, an effect believed to be due to dampening the harmful Th2 immune response detrimental to the outcome of asthma patients infected with rhinovirus. Those and other data were presented at the American Academy of Allergy, Asthma and Immunology meeting in San Diego.

Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C., presented phase I data at the American Academy of Allergy, Asthma and Immunology meeting in San Diego, showing that BCX4161, its oral kallikrein inhibitor, was general safe and well tolerated, with no serious or dose-limiting adverse events reported. The company also reported data of its plasma kallikrein inhibition assay, designed to determine the kallikrein inhibitory activity of the drug in activated plasma from normal subjects and those with hereditary angioedema (HAE). BCX4161 is currently being tested in a phase II trial OPuS-1, for the prevention of HAE attacks.

Conatus Pharmaceuticals Inc., of San Diego, said it started a phase II trial of lead candidate emricasan in patients with nonalcoholic fatty liver disease (NAFLD), including the subset of NAFLD patients with inflammatory and/or fibrotic nonalcoholic steatohepatitis (NASH). The double-blind, placebo-controlled trial is designed to enroll about 40 patients, who will be randomized 1-to-1 to receive either 25 mg of emricasan or placebo orally twice daily for 28 days and then followed for another 28 days. The primary endpoint is a reduction of elevated levels of key biomarkers implicated in patients with NAFLD/NASH. The study also will evaluate the safety and tolerability of emricasan in the target patient population. Top-line results are expected in the second half of this year.

Heat Biologics Inc., of Chapel Hill, N.C., said the first patient has been dosed in its phase I/II bladder cancer clinical study with product candidate, HS-410, which is designed to activate a T-cell mediated pan-antigen immune response to treat bladder cancer. The multicenter study will enroll approximately 93 patients and is designed to determine whether vaccination with HS-410 after transurethral resection of bladder tumor (TURBT) and bacillus Calmette-Guérin (BCG) extends the time to disease recurrence compared to placebo.

Intra-Cellular Therapies Inc., of New York, said it started a phase I/II study designed to evaluate the safety, tolerability and pharmacokinetics of low doses of its lead drug candidate, ITI-007, in healthy geriatric subjects and in patients with dementia, including Alzheimer’s disease. The two-part study will involve a multiple-ascending dose evaluation in healthy subjects, with about 10 subjects expected to be randomized per cohort to receive ITI-007 or placebo for seven days, as the first part. The second part of the trial will enroll 12 patients with dementia, who will be randomized to receive ITI-007 or placebo for seven days. Exploratory pharmacodynamics endpoints also will be included to assess feasibility of measuring agitation, sedation, sleep and cognition in potential future trials. Initial data from the study, dubbed ITI-007-200, is expected in the second half of this year.

LFB SA, of Framingham, Mass., through its Revo Biologics subsidiary, said it started a phase III program of LR769, a recombinant form of human factor VIIa, in patients with congenital hemophilia A or B with inhibitors. The initial phase III is an open-label study designed to evaluate the safety, efficacy and pharmacokinetics of LR769 in adolescent and adult patients, and initial results are expected in the second half of this year. The second study will assess the efficacy of LR769 for the treatment of bleeding episodes in pediatric hemophilia patients with inhibitors, while the third study will evaluate the prevention of bleeding complications in patients undergoing surgery. Both of those trials are set to start in early 2015.

S1 Biopharma Inc., of Jersey City, N.J., said it plans to initiate phase IIa trials in the third quarter for Orexa (S1P-205), its male hypoactive sexual desire disorder candidate (HSDD). Orexa is similar to the firm’s female HSDD drug Lorexys, which is designed to restore the balance of three neurotransmitters, but is specifically formulated for male HSDD.

Tapimmune Inc., of Seattle, reported analysis of interim data from the first set of patients in a phase I trial, showing that each of those patients have raised specific T-cell immune responses against a set of naturally processed HER2/neu class II antigenic epitopes. Those immune response data, the company said, support its contention that immune responses to its class II antigens should be found in up to 84 percent of the patient population, making it potentially applicable to a much wider spectrum of patients when compared to other HER2/neu therapies.