Antisense Therapeutics Ltd., of Victoria, Australia, reported that its Phase II trial of ATL1103 in acromegaly passed an interim analysis undertaken on eight patients who completed a full three months of dosing. Four patients received 200 mg of ATL1103 once per week and four received the higher dose of 200 mg twice per week. The interim analysis assessed the percentage reduction from each patient’s baseline serum insulin-like growth factor-I (sIGF-I). The goal in Phase III registration trials for acromegaly treatments is reduction in sIGF-I to normal range in a significant proportion of patients.
Pozen Inc., of Chapel Hill, N.C., said following ongoing interactions with the FDA concerning its new drug application for PA8140/PA32540 tablets, the company has decided to conduct a comparative Phase I pharmacokinetic study. The goal of the study is to determine the pharmacokinetic profile of the omeprazole component of PA8140 tablets and compare it to that of PA32540 tablets. Both dosage forms contain 40 mg of omeprazole in an immediate-release form and are manufactured using nearly identical procedures.
Redhill Biopharma Ltd., of Tel-Aviv, Israel, reported results of a pharmacokinetic study of RHB-105 for Helicobacter pylori infection showing positive results for pharmacokinetics, bioavailability and safety of the drug. Redhill said the results support continuation of the RHB-105 ERADICATE Hp Phase III study that is currently under way. RHB-105 is a fixed-dose combination of two antibiotics and a proton pump inhibitor.
Resverlogix Corp., of Calgary, Alberta, completed enrollment in its exploratory Phase II trial of RVX-208 in patients with pre-diabetes. The goal of the trial is to study insulin secretion, insulin sensitivity and other measures of diabetes and cardiovascular disease. About 20 patients have been enrolled, and data are expected in mid-2014.
Santarus Inc., of San Diego, began enrollment in a double-blind, placebo-controlled trial of SAN-300 in rheumatoid arthritis. The trial will enroll about 90 patients with active disease who have shown an inadequate response to disease-modifying antirheumatic drugs. The primary objective of the study is safety and tolerability with secondary endpoints of pharmacokinetics and pharmacodynamics, efficacy and immunogenicity. SAN-300 is a humanized monoclonal antibody designed to inhibit VLA-1, a cell adhesion molecule thought to play a role in inflammation.
Sucampo Pharmaceuticals Inc., of Bethesda, Md., reported Phase IIa proof-of-concept results for an intravenous ion channel activating compound for lumbar spinal stenosis. The randomized, double-blind, placebo-controlled trial enrolled 51 patients between the ages of 20 and 75 with confirmed diagnoses of lumbar spinal stenosis to receive 30 mcg or 60 mcg of drug or placebo twice daily for two weeks. A responder analysis of data from the trial showed that patients experienced a statistically significant improvement in pain compared to placebo (94.4 percent vs. 62.5 percent, p=0.035). The drug was well tolerated with no serious adverse events.