Ulcers

February 26, 2018

Celgene announced that data from the Phase III RELIEF clinical trial of OTEZLA (apremilast) in patients with active Behçet’s Disease with oral ulcers showed statistically significant reductions in oral ulcers with apremilast 30 mg twice daily (BID) versus placebo through week 12. OTEZLA (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4). The RELIEF study is a Phase III randomized, placebo-controlled, double-blind study evaluating apremilast 30 mg BID in 207 patients with active Behçet’s Disease who were previously treated with at least one topical or systemic medication. This 52-week study was conducted at 63 sites across ten countries. In the study, a total of 207 patients were randomized to apremilast 30 mg BID or placebo. At week 12, the area under the curve (AUC) for the number of oral ulcers was statistically significantly reduced with apremilast 30 mg BID versus placebo (129.5 vs. 222.1; P<0.0001), the trial’s primary endpoint. The most common adverse events observed in the trial were diarrhea (41.3 percent with apremilast, 19.4 percent for placebo), nausea (19.2 percent with apremilast, 10.7 percent for placebo), headache (14.4 percent for apremilast, 9.7 percent for placebo) and upper respiratory tract infection (11.5 percent for apremilast, 4.9 percent for placebo). This study primarily evaluated the effect of apremilast on recurring oral ulcers in patients with active Behçet’s Disease who were previously treated with at least one topical or systemic medication.

August 5, 2013

Pergamum reported results of a phase I/II study of LL-37 in patients with chronic leg ulcers. In the double-blind, multi-center study, 34 patients with venous leg ulcers received either placebo or one of three different doses of LL-37 (0.5mg/ml, 1.6mg/ml and 3.2mg/ml). Top-line results show patients treated with LL-37 for one month experienced an improved healing rate compared to placebo for the two lower doses. The average healing rate in patients receiving 0.5mg/ml or 1.6mg/ml was three to six times higher than in the placebo group, and this difference was statistically significant (p<0.05). The drug was well-tolerated when it was applied to venous leg ulcers at the two lower doses (0.5mg/mL and 1.6mg/mL). However, an increased incidence of local reactions at the treated wounds was observed in the highest dose group (3.2mg/ml) and there was no improvement in wound healing in comparison with placebo.

February 18, 2013

Pozen released results from two phase III trials of PA32540 for the treatment of endoscopic gastroduodenal ulcers. The blinded, randomized, multicenter studies enrolled 1,049 patients with previous cerebrovascular disease, who were prescribed daily aspirin (325mg) for at least three months for secondary prevention of cardiovascular events. Subjects received either once-daily PA32540 or enteric-coated aspirin 325mg. Post-hoc analysis of subjects with a history of transient ischemic attack or stroke, long-term treatment with PA32540, compared to enteric-coated aspirin, was associated with a significantly reduced rate of endoscopic gastroduodenal ulcers (2.0% vs. 12.4%, respectively; p=0.005). Furthermore, 85.1% of subjects on enteric-coated aspirin reported adverse events compared to 71.8% of subjects on PA32540. The drug was well tolerated. The most frequent adverse events were GI tract and include dyspepsia, erosive gastritis and gastritis.