• Arena Pharmaceuticals Inc., of San Diego, initiated dosing in a Phase I trial to evaluate APD791, an oral agent targeting treatment of arterial thromboembolic diseases. The Phase I trial will enroll up to 72 healthy adult volunteers and evaluate safety and tolerability of single ascending doses, as well as pharmacokinetics and pharmacodynamics. APD791 is selective inverse agonist of the 5-HT2A serotonin receptor.
• Medarex Inc., of Princeton, said partner Novartis Pharma AG, of Basel, Switzerland, advanced ACZ885, a fully human anti-IL-1 beta antibody, into a Phase III trial for Muckle Wells syndrome, a rare inherited inflammatory condition. That news triggers an undisclosed milestone payment to Medarex, which generated the antibody using its UltiMAb technology as part of the companies' collaboration agreement. Medarex could receive future milestone payments and royalties on potential commercial sales. Pending successful Phase III results, Novartis could seek regulatory approval in 2009.
• Mpex Pharmaceuticals Inc., of San Diego, started a Phase Ib trial of MP-376, its lead compound, in cystic fibrosis. MP-376 is an aerosolized formulation of levofloxacin aimed at treating chronic lung infections due to Pseudomonas aeruginosa in CF patients. Preclinical and early clinical studies suggested that active levofloxacin concentrations in pulmonary tissues after MP-376 administration are increased compared to those achieved when the antibiotic is delivered by other routes of administration. The Phase Ib study is expected to enroll about 39 patients and results from the study, along with prior clinical data, should support a Phase II study in 2008.
• Theratechnologies Inc., of Montreal, reported positive data related to body image from the first 26 weeks of its ongoing Phase III trial of TH9507 in HIV-associated lipodystrophy, a condition characterized by changes in the distribution of adipose tissue, dyslipidemia and glucose intolerance. Results showed that patients treated with 2 mg daily of TH9507 significantly improved their perception of belly image compared to the placebo group. Body image data is a secondary endpoint in the Phase III trial, and the company believes that addressing that problem would help remove a barrier for HIV treatment adherence. Data were presented at the International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV in Sydney, Australia. Late last year, Theratechnologies reported positive 26-week data in the trial's primary endpoint, the reduction of visceral adipose tissue (VAT) in HIV-associated lipodystrophy. (See BioWorld Today, Dec. 20, 2006.)