Alcobra Ltd., of Tel Aviv, Israel, said the FDA cleared its investigatonal new drug application for metadoxine extended release (MDX) and will allow for the initiation of U.S. trials. MDX has demonstrated significant efficacy and generally was well tolerated in two separate placebo-controlled phase II studies in adults with attentio deficit hyperactivity disorder.

Biotron Ltd., of Sydney, reported additional interim positive data from a phase II trial of lead antiviral drug, BIT225, in patients co-infected with HIV and hepatitis C virus (HCV). Analysis of patient blood samples suggested that HCV genotype 3 patients who completed treatment were free of virus at 24 weeks. The results extended previous data that showed patients had undetectable virus levels at 12 weeks.

Esperion Therapeutics Inc., of Plymouth, Mich., reported in conjunction with its 2013 year-end results that it plans this month to initiate the ETC-1002-009 phase IIb study of parallel doses of lead compound, ETC-1002, over 12 weeks added to statin therapy in patients with elevated LDL-cholesterol. The study is designed to demonstrate the ability of ETC-1002 to achieve incremental LDL-cholesterol lowering in approximately 132 patients with elevated levels. Esperion also plans to report final results of long-term chronic toxicology studies in the second quarter. In June 2013, the company raised approximately $70 million in an initial public offering to support midstage testing of its lead compound, ETC-1002, as an alternative to statin therapy (See BioWorld Today, June 27, 2013.)

Hepatera Ltd., of Moscow, enrolled 48 patients in the phase II trial of Myrcludex B for hepatitis B virus. The company is financed by Maxwell Biotech Venture Fund, set up with the participation of RVC, Russia’s government fund of venture capital funds. Hepatera was founded in 2011 with the goal of developing therapeutics for treatment of liver diseases for the Russian market. The objectives of the ongoing phase IIa trial are to study safety and tolerability, as well as efficacy of several dose levels of Myrcludex B in comparison to standard therapy (nucleoside analogues). Preliminary results are expected in June.

Kamada Ltd., of Ness Ziona, Israel, reported the initiation of a phase II/III trial of Glassia, a human alpha-1 antitrypsin (AAT), to treat newly diagnosed pediatric patients with type 1 diabetes (T1D). The trial of 190 pediatric patients with newly diagnosed T1D will evaluate the safety and efficacy of intravenous Glassia to halt disease progression and maintain the ability of the pancreas to produce insulin. The two-year study follows FDA and EMA guidelines for clinical trials evaluating beta cell preservation and will measure C-peptide parameters (which represent self-insulin secretion), HbA1C, hypoglycemic events and insulin daily dose, among others. Interim data are expected after approximately 90 patients complete one year of treatment, which will be in about two years. Initially, the trial will be conducted at four pediatric T1D medical centers in Israel with plans to expand the scope of the trial to include centers in other countries.

Omeros Corp., of Seattle, disclosed additional positive results from a phase IIa trial of OMS824, the company’s phosphodiesterase 10 (PDE10) inhibitor. Patients with schizophrenia were administered a higher dose than had been evaluated in any OMS824 trial, which resulted in approximately 50 percent higher plasma concentrations than did the previously reported highest dose and had a similar side-effect profile to those of the lower doses. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia and Huntington’s disease.

Verastem Inc., of Cambridge, Mass., offered preliminary data from an ongoing first-in-Asia phase I trial of VS-6063 in Japanese patients with advanced solid tumors, including one patient with mesothelioma. The study assessed the safety and pharmacokinetics of single agent VS-6063, and the company said outcomes were encouragingly consistent with a phase I study in the U.S.

Viralytics Ltd., of Sydney, said it commenced a phase I/II STORM (Systemic Treatment Of Resistant Malignancies) trial in cancer patients in the UK. The study will assess the multiple intravenous (systemic) delivery of Cavatak in approximately 30 patients with late-stage melanoma, prostate, lung or metastatic bladder cancers. In the first stage of STORM, Cavatak will be administered as a monotherapy in late-stage cancer patients. In the second stage, it will be administered in conjunction with commonly used chemotherapeutics, such as docetaxel or carboplatin/paclitaxel targeting only one cancer type, which will be identified as the most promising target from the first stage of the study.