The application was filed in continuation of a preliminary European patent application the company filed in May 2019. The application includes data from a disease model of inflammatory joint diseases, the K/BxN model in mice. This arthritis model is associated with the formation of immune complexes that drive the activation of immune cells, such as neutrophils and macrophages, and the release of a number of immune mediators including cytokines and chemokines. Hence, the model mimics active stages of RA, where AP1189 currently is tested in Phase II as add-on treatment to MTX. AP1189 has previously been tested in the model (see J Immunol. 194:3381-8, 2015), and in the new dataset filed with the patent application the compound, at a sub maximal dose was given in combination with MTX. The study groups of animals were treated with either vehicle (controls), MTX, the sub-maximal dose of AP1189, or a combination with AP1189 and MTX. Treatment was started when arthritis symptoms were present, and the treatment effects were evaluated on day 7. At this timepoint, 75% of the vehicle-treated animals had developed severe disease defined as a clinical score of more than 10. In both the MTX and the AP1189 groups, 50% of the animals had developed severe disease. In the group of animals treated with the combination of AP1189 and methotrexate, no animals developed severe arthritis suggesting synergistic effects of AP1189 and MTX in RA. Further, no signs of toxicity were found in the animal treated with the AP1189 and MTX combination. The patent application will be public within 6 months from filing.
Thomas Jonassen, CSO SynAct Pharma states:
“The purpose of the patent application is to add an additional level of IP protection to our AP1189 compound. As the data generated in the animal model of RA suggest synergistic effects of AP1189 and MTX when given in combination, we have filed the claims for combination treatment of the compounds as applied in our ongoing Phase 2 study in RA. In addition to giving a broader patent protection, if granted as filed, this patent will also extend the patent runway for such combination therapy.”