Phase 1/2 Clinical Trial to assess the safety and preliminary efficacy of Lipoxin Analog BLXA4-MEOral Rinse for the Treatment of Gingivitis

项目总结

Project Summary This application seeks funding to complete an ongoing Phase 1/2 Clinical Trial to assess the safety and preliminary efficacy of Lipoxin Analog BLXA4-ME Oral Rinse for the Treatment of Gingivitis. The study comprises 3 groups in a randomized, placebo-controlled, double-blind clinical trial design, a treatment group, the placebo rinse group and the no-rinse control group. The treatment group (1.0 μM BLXA4-ME oral rinse) and the placebo rinse group include 50 subjects. The no-rinse control group consists of 25 subjects. Subjects in the treatment and placebo rinse groups receive oral rinse (BLXA4-ME or placebo) to be used once daily after morning teeth brushing. Safety parameters will be assessed before treatment and 3, 7, 14, 21, and 28 days after initial treatment. Efficacy parameters will be assessed before treatment and 14 and 28 days after initial treatment. The primary objective is to evaluate the safety of an investigational compound, BLXA4-ME, topically applied as a daily oral rinse in adults with gingival inflammation. Safety assessments will include the incidence of adverse events, including mucosal inflammation and irritancy, and findings from safety laboratory tests. Subjects will be monitored for development or progression of periodontitis and oral flora will be analyzed to detect an increase in opportunistic organisms. The secondary objective is to assess preliminary efficacy of the oral rinse, by monitoring changes in the plaque index (PI), modified gingival index (MGI), bleeding on probing (BOP) sensitivity, levels of interleukin-1β (IL-1β) in gingival crevicular fluid (GCF) and changes in the specialized lipid mediator profile in serum before and after treatment. The active preparation (test rinse) will contain BLXA4-ME at 1.0 μM in a formulated oral rinse containing 10% ethanol and 0.25% sodium lauryl sulfate. The compound BLXA4-ME is an analog of lipoxin A4, a locally acting lipid mediator biosynthesized from the essential fatty acid, arachidonic acid. In BLXA4-ME, a fused o-substituted benzo-ring is incorporated between 2 positions of the tetraene unit of native lipoxin A4. The placebo preparation will consist of formulated oral rinse without BLXA4ME. The duration of participation of each subject is approximately 3 months (visits through 28 days plus safety follow-up phone call 2 months after last product use). The recruitment rate is approximately 20 subjects per month of which 6-8 are randomized. Based upon this rate, it is estimated that enrollment will be completed in 12 months.