• Anacor Pharmaceuticals Inc., of Palo Alto, Calif., disclosed positive results from a Phase II safety, pharmacokinetics and efficacy trial of its boron-based phosphodiesterase-4 inhibitor, AN2728, in adolescents, ages 12 to 17, with mild to moderate atopic dermatitis. The 23-patient study showed that 74 percent of patients achieved an Investigator Static Global Assessment (ISGA) score of zero or 1 after four weeks of treatment, and 35 percent achieved an ISGA score of zero or 1 with a minimum two-grade improvement after four weeks.

• Biotie Therapies Corp., of Turku, Finland, reported top-line data from a Phase IIb study showing that tozadenant (SYN115), its adenosine A2a antagonist, met the primary endpoint of decreasing the "off" time in Parkinson's patients experiencing levodopa-related end-of-dose wearing off vs. placebo. The drug also demonstrated efficacy across multiple secondary endpoints. The study enrolled 420 patients.

• Durata Therapeutics Inc., of Chicago, disclosed preliminary, top-line results for its DISCOVER 1 (Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response) Phase III study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. Results showed that dalbavancin achieved its primary endpoint of noninferiority at 48 hours to 72 hours after initiation of therapy, as determined by the cessation of spread of the lesion, as well as the resolution of fever. Researchers compared two intravenous doses of dalbavancin given one week apart with twice-daily vancomycin doses for 14 days. Durata said the key secondary endpoints were supportive of the primary endpoint. The DISCOVER 1 protocol was conducted pursuant to a special protocol agreement with the FDA. (See BioWorld Today, April 20, 2011.)

• Ligand Pharmaceuticals Inc., of San Diego, started a pivotal trial with Captisol-enabled, propylene glycol-free (PG-free) high-dose melphalan as a conditioning treatment prior to autologous transplant for patients with multiple myeloma. The trial will evaluate safety and efficacy in 60 patients, and is intended to confirm the results from an earlier Phase II study demonstrating that the PG-free melphalan intravenous formulation was safe and well tolerated, and met the requirements for establishment of bioequivalence to the current commercial intravenous formulation of melphalan (sold by GlaxoSmithKline plc, of London, as Alkeran for injection). Should the pivotal trial produce positive results, the company said it will be in a position to submit a new drug application via the 505(b)(2) pathway.

• uniQure BV, of Amsterdam, the Netherlands, said it started a Phase I trial in acute intermittent porphyria (AIP). A total of eight patients will be enrolled, and the primary objective is to evaluate safety and determine the maximum-tolerated dose. Interim results are expected in the third quarter of 2013. The study is being conducted under the aegis of the AIPGENE consortium, a pan-European collaboration funded in part by the European Commission's Seventh Framework Program, with the aim of developing a gene therapy for the treatment of AIP, a rare disease caused by the porphobilonogen deaminase gene. uniQure previously received orphan drug designation in Europe for AIP.