• Adolor Corp., of Exton, Pa., started a Phase I trial of ADL7445, an oral mu opioid receptor antagonist for opioid-induced bowel dysfunction. The study will enroll healthy volunteers to test a single ascending dose, followed by a multiple ascending dose study in early 2010.

• ArGentis Pharmaceuticals LLC, of Memphis, Tenn., is collaborating with the University of Tennessee Health Science Center and the Veterans Affairs Medical Center in Memphis to initiate a Phase I study of ARG301, an oral, altered peptide ligand, in rheumatoid arthritis patients. The study will enroll 42 patients to receive multiple ascending doses, with the primary objectives to determine if one or more of the three doses can generate functional T regulatory cells and decrease immune reactivity to Type II collagen.

• Cequent Pharmaceutical Inc., of Cambridge, Mass., filed an investigational new drug application for CEQ508, an oral tkRNAi candidate designed to target beta-catenin, in familial adenomatous polyposis patients. The study, set to start in the first quarter of 2010, would involve a total of 18 adult FAP patients. A key readout and secondary objective of the study includes analysis of biomarker expression changes in the gastrointestinal tract of patients determined from biopsy samples taken prior to receiving the drug and following a daily, 28-day dosing regimen.

• Optimer Pharmaceuticals Inc., of San Diego, completed enrollment in the second of two pivotal Phase III trials of fidaxomicin in Clostridium difficile infection. Top-line data are expected in the first quarter of 2010. Results from the first Phase III trial, reported a year ago, showed a 92.1 percent cure rate and 13.3 percent recurrence rate for fidaxomicin compared to an 89.8 percent cure rate and 24 percent recurrence rate for Vancocin (vancomycin, ViroPharma Inc.). If results from the second study are positive, Optimer expects to file a new drug application in 2010. (See BioWorld Today, Nov. 12, 2008.)

• Tobira Therapeutics Inc., of Princeton, N.J., reported data from two Phase II studies of TBR-652 in 84 healthy volunteers, showing that the drug was well tolerated at single daily doses up to 800 mg and once-daily doses of up to 200 mg for 10 days. Data were presented at the European AIDS Conference in Cologne, Germany.