• Alk-Abello A/S, of Horsholm, Denmark, disclosed a positive outcome of the second of two pivotal Phase III trials of its allergy immunotherapy tablet for the treatment of house dust mite-induced respiratory diseases. The MITRA trial met its primary endpoint and demonstrated a significant reduction in the risk of moderate to severe asthma exacerbations. The trial also demonstrated that the treatment was well tolerated and had a favorable safety profile.

• Auspex Pharmaceuticals Inc., of La Jolla, Calif., said it enrolled the first patient in a Phase III pivotal study, First-HD, of SD-809 for the treatment of involuntary movements associated with Huntington's disease. The four-month study will enroll patients who have not previously taken tetrabenazine, and the primary endpoint will be Total Maxima Chorea score. Secondary endpoints will include treatment success measurements based on patient and clinical global impressions of change. Top-line data are expected in 2014. In parallel with the First-HD trial, Auspex said it will conduct an open-label study of SD-809 in experienced tetrabenazine users and in subjects who complete First-HD.

• Biodel Inc., of Danbury, Conn., said scheduled follow-up visits were completed for patients enrolled in the Phase II trial of BIOD-123, its ultra-rapid-acting injectable mealtime insulin therapy. The randomized, open-label, parallel group study enrolled 132 patients with Type I diabetes, randomized to BIOD-123 or Humalog (insulin lispro, Eli Lilly and Co.) to use as mealtime insulin during an 18-week treatment period. The trial is designed to evaluate HbA1c control as the primary endpoint, with secondary endpoints of postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes. The company expects to report top-line data by the end of the third quarter.

• Echo Pharmaceuticals BV, of Amsterdam, said Namisol completed a Phase II trial in 24 patients suffering from spasticity and pain due to multiple sclerosis, with results showing efficacy and consistent data on both spasticity and pain. Namisol is an oral tablet containing pure (>/= 98 percent) natural Δ9-tetrahydrocannabinol in fixed dosages.

• Emergent Biosolutions Inc., of Rockville, Md., said its pivotal Phase III study evaluating the immunogenicity and safety of a three-dose regimen of Biothrax (anthrax vaccine adsorbed) in post-exposure prophylaxis (PEP) met its primary and key secondary endpoints. The company submitted the final clinical study report to the Biomedical Advanced Research and Development Authority and the FDA and plans to use the results to support a supplemental biologics license application for a Biothrax PEP indication. The open-label Phase III study enrolled 200 healthy adults. The company plans to present data from the study at the International Conference on Bacillus anthracis, B. cereus, and B. thuringiensis in September. Additionally, Emergent said data from nonclinical and clinical PEP studies that preceded the Phase III study were published in Clinical and Vaccine Immunology.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., reported results from the most recent safety monitoring committee review for the company's NX02-0017 trial, one of the two Phase III pivotal trials for NX-1207, in benign prostatic hyperplasia. The committee found no significant safety concerns to date, and the trial is ongoing.

• Pluristem Therapeutics Inc., of Haifa, Israel, said it completed target enrollment in a randomized, double-blind, placebo-controlled Phase I/II trial in Germany assessing the safety and efficacy of its placental expanded (PLX) cells to treat traumatized muscles. Patients were treated with PLX-PAD cells or placebo and are currently in follow-up.

• Psivida Corp., of Watertown, Mass., said interim data from a three-year, investigator-sponsored Phase I/II study of its injectable micro-insert in patients with posterior uveitis showed none of the treated eyes had a recurrence of uveitis through the first 12 months of enrollment, and inflammation was reduced in all treated eyes. By contrast, untreated eyes showed either recurrence of uveitis or worsening or no improvement in inflammation. At the last follow-up visit, best corrected visual acuity improved by an average of more than nine letters in treated eyes compared to a decline by an average of one letter in untreated eyes. The micro-inserts were well tolerated and the safety profile was consistent with the short-term safety profile reported in clinical studies of Iluvien (fluocinolone acetonide intravitreal insert) in patients with diabetic macular edema. The micro-insert is marketed in the European Union as Iluvien by Psivida's collaborative partner, Alimera Sciences Inc., of Atlanta. Psivida, which is developing the uveitis application independently, recently initiated the first of two Phase III trials enrolling a total of some 300 patients to study the use of the micro-insert in posterior uveitis, with a primary endpoint of recurrence of uveitis within 12 months.

• Redhill Biopharma Ltd., of Tel Aviv, Israel, said it started dosing in the first of two supplementary pharmacokinetic studies with RHB-102, an oral, extended-release formulation of ondansetron, the active ingredient in immediate-release Zofran (Glaxosmithkline plc), which is approved for the prevention of radiotherapy-induced nausea and vomiting and chemotherapy-induced nausea and vomiting. The studies follow a Type B meeting held with the FDA in February. The first study will include 14 healthy volunteers and is intended to assess the effect of food on the absorption of RHB-102. In August, the firm will initiate a supplementary comparative bioavailability study with RHB-102, with Zofran as the reference drug. Results are anticipated by October and, if positive, Redhill expects submitting a new drug application in the first quarter of 2014.