Hyloris Reports Positive Phase 1 Data for HY-004, a proprietary Tranexamic Acid Oral Mouth Rinse for bleeding related to dental procedures
- HY-004 provides a new treatment alternative for use in patients on anti-coagulant therapies undergoing dental procedures that have a risk of bleeding or complication
- HY-004 administered locally had minimal systemic exposure and was well-tolerated following molar extraction in healthy patients
- HY-004 to be developed to address a significantly larger target market
- Pivotal study expected to start early next year to usher HY-004 into later stage development
Regulated Information – Inside Information
Liège, Belgium - 20 July 2022 -
“Tranexamic acid is an antifibrinolytic agent that has been used for decades intravenously to reduce or prevent postoperative bleeding in patients with bleeding problems, however, it has not been approved in a locally acting form to optimally enable coagulation following dental procedures”, said
About HY-004
Hyloris HY-004 is a proprietary reformulated oral rinse 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.
About Tranexamic Acid
Tranexamic acid is an antifibrinolytic agent 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
About
Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimizing existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors. Hyloris has built a broad, patented portfolio of 14 reformulated and repurposed value-added medicines that have the potential to offer significant advantages over available alternatives. Outside of its core strategic focus, the Company also has 4 high barrier generic products in development. Two products are currently in initial phases of commercialization with partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative pain treatment. The Company’s development strategy primarily focuses on the FDA’s 505(b)2 regulatory pathway, which is specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This pathway can reduce the clinical burden required to bring a product to market, and significantly shorten the development timelines and reduce costs and risks. Hyloris is based in Liège,
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Disclaimer and forward-looking statements
Hyloris means “high yield, lower risk”, which relates to the 505(b)(2) regulatory pathway for product approval on which the Company focuses, but in no way relates or applies to an investment in the Shares. Certain statements in this press release are “forward-looking statements.” These forward-looking statements can be identified using forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties, and other factors, many of which are beyond the Company’s control, that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
1 IBM Truven Health Analytics, 12 months ending December 31, 2018 for Commercial, Medicare and Medicaid patients
2 65.5% of
Attachment
- HYL_Tranexamic_phase_1_results_EN_Final_corrected
Source:
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