DEVELOPMENT OF A BIOLOGICAL DRUG FOR TREATMENT OF ORAL INDICATIONS PERIODONTITIS AND PERI-IMPLANTITIS

Purpose and goal

The aim was to develop two plasminogen-based drug candidates for treatment of periodontitis and peri-implantitis. The goal was an injectable substance and a paste / ointment / granule for topical application. The work with injectable plasminogen for treatment of periodontitis has progressed well using our mouse models. For topical treatment we have identified that a carrier substance (Lyostypt) which is already used in oral indications can adsorb plasminogen and thus be used as a carrier material. The work on peri-implantitis was technically very difficult but is still on-going.

Expected results and effects

We have discussed with experts to evaluate and select a proper treatment strategy as well as the regulatory requirements. Since our industrial partner sold the plasminogen production capacity we decided to produce recombinant GMP-plasminogen on our own. Funding for this was obtained through a private placement and a CMO has been selected. A letter of intent for the financing of the project through clinical trials have been obtained. The periodontitis and peri-implantitis models in rodents have been optimized. Formulation studies for topical formulations have been performed.

Planned approach and implementation

We now have found investors that in three rounds will finance the development of plasminogen to a drug product and finance the first clinical trial. The first investment round that we have obtained are used to produce GMP-quality recombinant plasminogen which is on-going. Development of formulations for topical treatment are in progress using our animal models.