• Achillion Pharmaceuticals Inc., of New Haven, Conn., said it started a Phase II trial of sovaprevir and ACH-3102, in combination with ribavirin, for the treatment of genotype 1 chronic hepatitis C virus patients who have not received prior therapy. The study will evaluate the all-oral, 12-week, interferon-free regimen for safety, tolerability and efficacy in up to 50 patients. Initially, 30 patients will be enrolled and randomized to receive either a combination of sovaprevir, ACH-3012 and ribavirin or matching placebos. Primary endpoints include sustained virologic response at four weeks.

• Bone Therapeutics SA, of Gosselies, Belgium, said its partner, the Rheumatology Department of Erasme University Hospital in Brussels, Belgium, initiated a Phase IIa trial testing lead bone cell therapy product, Preob, for the treatment of severe osteoporosis patients who do not respond to pharmacological treatment. The six-month, open-label trial is expected to enroll 20 patients to receive Preob via a single intravenous infusion. The primary endpoints will be cell body distribution and bone markers. Preob is an autologous osteoblastic cell therapy currently in two pivotal Phase III trials to treat osteonecrosis and nonunion fractures.

• GlycoMimetics Inc., of Gaithersburg, Md., reported top-line results from a Phase II study showing that patients with vaso-occlusive crisis of sickle cell disease who were treated with GMI-1070 experienced reduction in duration of vaso-occlusive crisis, reduction in length of hospital stay and reduction in the use of narcotic pain relief. Both adult and pediatric patients demonstrated improvement, and adverse event rates were comparable between GMI-1070 and placebo. The Phase II study enrolled 76 patients, ages 12 to 60. GlycoMimetics partnered GMI-1070, a synthetic glycomimetic molecule designed to inhibit all three selectin types, in a worldwide agreement with Pfizer Inc., of New York, in 2011. (See BioWorld Today, Oct. 12, 2011.)

• Nektar Therapeutics Inc., of San Francisco, said partner Bayer AG, of Leverkusen, Germany, initiated patient enrollment in a Phase III program to test adjunctive aerosolized BAY41-6551 vs. aerosolized placebo in the treatment of intubated and mechanically ventilated patients with Gram-negative pneumonia receiving standard-of-care intravenous antibiotics. BAY41-6551 consists of amikacin inhalation solution delivered by a pulmonary drug delivery system developed by Nektar.

• Northwest Biotherapeutics Inc., of Bethesda, Md., said its Phase III study testing DCVax personalized immune therapy in glioblastoma multiforme was "adopted" as a national priority trial in the UK. That designation, under the program managed by the National Institute for Health Research, carries resources and operational support for the trial sites.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., reported findings demonstrating that its NX-1207 for benign prostatic hyperplasia has no detectable effect on key male structures involved in sexual function. NX-1207 is in Phase III testing.

• Rhythm Pharmaceuticals Inc., of Boston, said it started an additional Phase II trial of RM-131, its ghrelin agonist, for the treatment of chronic constipation. The study is designed to evaluate the drug's effects on symptoms and lower gastrointestinal function in patients with significant chronic constipation, assessing both efficacy and safety of RM-131 administered daily for two weeks. About 48 patients are expected to be enrolled.