• Addex Pharmaceuticals, of Geneva, Switzerland, presented positive data from a Phase IIa trial of ADX10059 to treat gastroesophageal reflux disease (GERD). In the three-day trial, 24 GERD patients were given three meals each day designed to provoke episodes, and given ADX10059 half an hour before each meal. A pH senor in the lower esophagus of each patient showed there was a reduction in the number of episodes and duration of episodes where the pH dropped by more than one pH unit. ADX10059 is an orally available small-molecule compound that works as a negative allosteric modulator (an inhibitor) of the metabotropic glutamate receptor 5 (mGluR5). The data were presented at the United European Gastroenterology Week conference in Paris.

• BioLineRx Ltd., of Jerusalem, said interim results from its ongoing, open-label Phase II trial of the GABA enhanced antipsychotic BL-1020 showed that the drug reduced the Positive and Negative Syndrome Scale total score by 26.1 points from baseline (p<0.001) and the negative score by 7.1 points from baseline (p<0.001). Clinical Global Impression scores showed that 92.35 percent of patients improved by at least one category. Adverse events were minimal to mild and not treatment-limiting. Final data are expected by the end of the year.

• Celtic Pharmaceutical Holdings LP, of New York, completed enrollment of more than 520 patients into its double-blind, placebo-controlled, dose-ranging Phase IIb trial of the vaccine TA-NIC for nicotine addiction. The primary endpoint of the study is smoking abstinence at six months, and initial data are expected in the second quarter of 2008. Celtic said it plans to auction the product at that time.

• Coley Pharmaceutical Group Inc., of Wellesley, Mass. dosed its first subject in a Phase I safety study of its oral toll-like receptor drug for systemic lupus erythematosus. CPG 52364 is a small-molecule TLR antagonist designed to specifically inhibit TLRs 7, 8 and 9 and inhibit disease development in SLE and other autoimmune disorders. The compound is designed to interfere at an early stage of the immune cascade by blocking the inappropriate immune activation of all three of the TLRs, and to treat the underlying cause of the disease without causing general suppression of immune function, Coley said. The Phase I study is a double-blind, placebo-controlled, randomized trial in about 40 healthy volunteers.

• Epix Pharmaceuticals Inc., of Lexington, Mass., said a randomized, double-blind, placebo-controlled Phase Ib trial showed that obese patients on PRX-07034 lost an average of 0.45 kg (1 pound) after 28 days of treatment, while the placebo group gained an average of 1.37 kg (3 pounds) (p<0.005). PRX-07034 was well tolerated, although the company said QT prolongation findings will result in the R-enantiomeric form of the 5-HT6 antagonist being used moving forward. The National Institute of Mental Health selected the drug for clinical trials. Separately, Epix said enrollment has been completed in a Phase IIb trial of PRX-00023 for major depressive disorder and in a Phase IIa trial of PRX-03140 for Alzheimer's disease.

• Gilead Sciences Inc., of Foster City, Calif., presented Phase III data indicating that virologically-suppressed HIV patients taking Sustiva (efavirenz, Bristol-Myers Squibb Co.) who switched from combination therapy with Combivir (lamivudine and zidovudine, GlaxoSmithKline plc) to combination therapy with Gilead's Truvada (emtricitabine and tenofovir disoproxil fumarate) maintained virological suppression and decreased certain side effects. Specifically, limb fat and hemoglobin levels increased for Truvada patients and decreased for those remaining on Combivir (p=0.025 and p<0.001, respectively). The data were presented at the 11th European AIDS Conference.

• Shire plc, of Basingstoke, UK, offered scientific data on its attention deficit hyperactivity disorder treatments at a meeting of child and adolescent psychiatrists in Boston, including results of the first Vyvanse study in adults with the disorder, as well as findings from a 12-month study on Daytrana, the first and only patch for ADHD approved by the FDA. Vyvanse was cleared by the FDA in late February for children and launched several months later.