Hyloris Pharmaceuticals SA announced that the first patient has been enrolled in a pivotal Phase 3 clinical trial for Tranexamic Acid Oral Rinse. Hyloris' product candidate is a new treatment for use in patients on anti-coagulant therapies (blood thinners) undergoing dental procedures with a risk of excessive bleeding. It is an oral solution containing the locally-acting antifibrinolytic agent tranexamic acid.

Positive data in a Phase 1 pharmacokinetic (PK) trial in healthy subjects suggested the treatment was well tolerated under varied conditions with no serious adverse events following tooth extraction, while effectively controlling procedural bleeding without delaying clot formation. Hyloris' proprietary reformulated oral rinse was developed for use in minor surgical procedures with complications/bleedings. The formulation can be used by dental care professionals for patients on anti-coagULant therapies who benefit from the opportunity to continue their anti-coagulant treatments when scheduled for dental procedures.

By addressing the unique challenges faced by individuals on blood thinners, this oral care solution seeks to enhance the overall dental experience and improve the oral health of these patients. Tranexamic acid is an antifibrinolytic agents that has been used for decades to reduce or prevent postoperative bleeding in patients with bleeding problems. The drug is currently approved for intravenous administration (CYKLOKAPRON®? IV) in the U.S. for reduction or prevention of bleeding in patients having a high risk of intra and post-operative haemorrhage (during general and oral surgery, such as tooth extractions) due to a bleeding disorder such as haemophilia (as indicated).

The drug is also approved in the U.S. as an oral tablet (LYSTEDA®?) for cyclic heavy menstrual bleeding.