Hyloris Pharmaceuticals has enrolled the first patient in a phase III trial for its oral rinse that controls bleeding during and after procedures in dental patients who are taking anticoagulants.
Approximately 280 patients at 20 clinical sites in the U.S. and European Union will be randomized to receive either the rinse, which contains the locally acting antifibrinolytic agent tranexamic acid, or a placebo for seven days. The participants will be monitored for about one month, according to a company press release dated February 14.
Currently, tranexamic acid is approved in the U.S. for IV administration to reduce or prevent bleeding in patients at high risk for intra- and postoperative hemorrhage. Also, a tablet form of the drug is approved in the U.S. for cyclic heavy menstrual bleeding. In the U.S, about 8 million people take blood-thinning medications.
Recruitment for the phase III trial, which aims to show the efficacy, safety, and acceptability of the oral rinse to prevent possible hemorrhaging in patients treated with anticoagulants and undergoing the extraction of one or more teeth, is expected to be completed by the end of 2024. Final results are expected to be available in the first half of 2025.
The phase I trial completed in healthy patients suggested the treatment controlled procedural bleeding without delaying clot formation with no adverse effects. Also, this phase defined the optimal administration regimen for the mouth rinse, according to the company.
Hyloris will seek regulatory approval of the rinse in the U.S. before expanding to other places. Conditional to a successful clinical study, Hyloris expects to license the oral rinse to a partner for commercialization in the U.S.
Additionally, Hyloris is exploring opportunities in broader related indications in patients undergoing oral surgical procedures with or without bleeding disorders that could benefit from an antifibrinolytic agent, according to Hyloris.
