• Acorda Therapeutics Inc., of Hawthorne, N.Y., said the first patient was enrolled in a proof-of-concept study exploring the use of Ampyra (dalfampridine) extended-release tablets in treating patients who have post-stroke deficits, which refer to chronic neurological deficits that persist in people who have suffered strokes. The trial is designed to assess the safety and tolerability of Ampyra in subjects with stable post-stroke deficits after an ischemic stroke, and exploratory outcome measures will include changes in walking speed, upper and lower extremity motor and sensory function, manual dexterity, assessment of functional independence in performing activities of daily living and clinician and subject global impressions of general improvement. The study will recruit about 66 people, and data are expected in early 2013.

• Alkermes plc, of Dublin, Ireland, said Janssen Research & Development LLC, a unit of Johnson & Johnson, of New Brunswick, N.J., initiated a Phase III program for a three-month formulation of Invega Sustenna (paliperidone palmitate), a once-monthly injectable for the treatment of schizophrenia approved by the FDA in 2009. Invega Sustenna is being developed by Janssen Pharmaceutica NV, which licensed Alkermes' technology for nanoparticles. Two Phase III studies are expected to enroll approximately 1,800 patients with schizophrenia to assess the efficacy, safety and tolerability of the three-month injectable formulation. The studies are expected to be completed in the second half of 2014. (See BioWorld Today, Aug. 10, 2009, and May 10, 2011.)

• Cempra Inc., of Chapel Hill, N.C., dosed the first two patients in its Phase II trial evaluating the efficacy, safety and tolerability of solithromycin in uncomplicated urogenital gonococcal infections. The open-label study will treat 30 patients with uncomplicated gonorrhea with a single 1,200-mg oral dose of solithromycin. The primary outcome is bacterial eradication at test of cure, which is seven days following treatment. The company expects to report top-line results by the end of the year.

• Cytokinetics Inc., of South San Francisco, said data from its Phase II EoE (Evidence of Effect) study of CK-2017357, an oral fast skeletal muscle troponin activator, in patients with amyotrophic lateral sclerosis were published in Amyotrophic Lateral Sclerosis. Results demonstrated that single oral doses of 250 mg and 500 mg of the drug appeared safe and well tolerated. Measures of muscle endurance also appeared to be improved in a dose-related fashion in patients who received CK-2017357.

• Halozyme Therapeutics Inc., of San Diego, reported Phase II results showing that its prandial insulin formulations, including its recombinant human hyaluronidase (rHuPH20) enzyme, met the primary endpoint in patients with Type I diabetes, showing A1C noninferiority. Data also indicated that rHuPH20 reduced postprandial glycemic excursions, as well as significantly reduced hypoglycemic events. Findings were presented at the American Diabetes Association meeting in San Diego.

• Noscira SA, of Madrid, Spain, said the data and safety monitoring board recommended that the ongoing ARGO trial continue without modifications. ARGO (Alzheimer's Research in GSK-3 mOdulation) is testing the effects of tideglusib, a glycogen synthase kinase 3 inhibitor, vs. placebo in daily doses for 26 weeks. About 306 patients are involved, and preliminary data are expected before the end of this year.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said it enrolled the first patient for Study NX03-0040, a Phase II study testing NX-1207 in low risk localized prostate cancer. The trial will evaluate both high and low doses of the drug, and efficacy will be assessed six weeks after treatment. NX-1207 also is in Phase III development for benign prostatic hyperplasia.

• Pharmanest AB, of Stockholm, Sweden, said it dosed the first patient in a Phase II study of SHACT, a product developed for pain relief associated with intrauterine device (IUD) insertion. The goal of the study is to evaluate the effect of SHACT in connection with IUD insertion, and secondary objectives include safety and tolerability. Karolinska Development AB owns 58.9 percent of Pharmanest.

• PsychoGenics Inc., of Tarrytown, N.Y., reported positive results from a study of eltoprazine in levodopa-induced dyskinesia (LID) in Parkinson's disease. The randomized, dose-finding study was conducted at two sites in Sweden, where 22 patients were given single doses of eltoprazine and placebo along with a challenge dose of levodopa at each of five treatment visits and assessed for parkinsonian and dyskinesia symptoms over a period of three hours post-treatment. Primary efficacy was measured using the Clinical Dyskinesia Rating Scale and the Unified Parkinson's Disease Rating Scale. Eltoprazine met the primary objective of the study by exhibiting a statistically significant reduction in LID at the 5-mg dose (p = 0.0007) and the 7.5-mg dose (p = 0.0467), without adversely affecting levodopa efficacy. The selective 5-HT1A/1B partial agonist was well tolerated, with no serious adverse events.

• Savara Inc., of Austin, Texas, reported positive top-line data from its Phase I study of AeroVanc in patients with cystic fibrosis (CF). AeroVanc, a dry powder formulation of vancomycin, is an inhaled antibiotic in development for respiratory methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with CF. The dose-escalating study examined the compound's tolerability, safety and pharmacokinetics in non-MRSA infected CF patients, demonstrating AeroVanc was safe and well tolerated and produced high concentrations of vancomycin in the sputum. In line with pharmacokinetic results in healthy volunteers, clearance of vancomycin from the lungs was slow, indicating a favorable profile for once- or twice-daily dosing.

• Summit plc, of Oxford, UK, achieved a dosing milestone in its Phase I trial of SMT C1100 in the genetic disease Duchenne's muscular dystrophy (DMD), triggering the final payment from a $1.5 million funding agreement with U.S.-based DMD organizations the Muscular Dystrophy Association, Charley's Fund, Cure Duchenne, the Foundation to Eradicate Duchenne, Nash Avery Foundation and Parent Project Muscular Dystrophy. SMT C1100, an oral small-molecule compound, is designed to up-regulate the naturally occurring protein utrophin. The dose-escalation study in healthy volunteers, initiated in May, has progressed to multiple doses, with results expected by the end of the year.

• VaxInnate Corp., of Cranbury, N.J., started a Phase I trial to test VAX161 , an H5 vaccine candidate in development for the prevention of pandemic avian influenza. The dose-ranging study, which is being conducted under the firm's contract with the Biomedical Advanced Research and Development Authority, will evaluate the safety and immunogenicity of VAX161, administered by intramuscular injection three weeks apart at six dose levels. The study is expected to include 250 healthy adults, ages 18 to 49. Results are expected later this year.