Oxurion NV (Euronext Brussels: OXUR) a biopharmaceutical company developing next generation standard of care ophthalmic therapies, with clinical stage assets in vascular retinal disorders, announced today that it has prevailed in final proceedings before the European Patent Office in opposition to Dyax Corp.’s European patents 1 854 477 and 2 374 472. The European Board of Appeal announced its decision at a hearing on November 15, 2022.
With this final decision, Oxurion further improves its intellectual property position over THR-149, its novel therapeutic for the treatment of diabetic macular edema (DME). Oxurion itself holds granted patents for THR-149 through 2034 with the potential to extend through 2039.
“We are pleased with the Appeal Board’s final decision revoking the Dyax claims ,” said Tom Graney, CEO of Oxurion. “We are very proud of our work with THR-149 and removing these claims will assist Oxurion in capturing the long-term value of this important asset.”
THR-149 is a bicyclic peptide that selectively inhibits human plasma kallikrein (PKal) with an inhibition constant of 0.22 nM. Through the inhibition of the kallikrein-kinin system (KKS), THR-149 prevents the induction of retinal vascular permeability, neurodegeneration, and inflammation.
THR-149 is currently being evaluated in the KALAHARI Phase 2, Part B clinical trial as a potential treatment for patients who respond suboptimally to anti-VEGF standard of care for treatment of DME. DME is the leading cause of vision loss in working-age people, and the market for treatments is currently estimated at $5+ billion. Results of an interim analysis of the KALAHARI Phase 2, Part B trial are expected by year-end 2022.
Part B of the KALAHARI study follows a successful Part A, in which three dose levels of THR-149 (0.005mg, 0.022mg and 0.13mg), were each administered in three monthly IVT injections, whch were then evaluated in order to select the best dose for Part B of the study.
High-level data from Part A of the KALAHARI trial was first presented in October 2021, which demonstrated that the eight patients who received the highest dose of THR-149, achieved a mean BCVA gain of 6.1 letters at Month 3, the primary endpoint. A post-hoc analysis was performed by the masked central reading center in February 2022 based on an OCT (Optical Coherence Tomography) biomarker assessment.
The masked reading center identified two subjects with abnormalities at baseline, which could impact responsiveness to any medical treatment. Excluding these two subjects resulted in an improvement in mean BCVA of 9.3 letters at Month 3, which was sustained until Month 6, the end of the trial. The Month 6 data also demonstrated THR-149’s attractive safety profile and its ability to stabilize the Central Subfield Thickness (CST). The learnings from the Part A data were incorporated into Part B through an amended study design excluding patients that would not respond to any treatment. More information can be found here: NCT04527107
Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to improve and better preserve vision in patients with retinal disorders including diabetic macular edema (DME), the leading cause of vision loss in working-age people, as well as other conditions. Oxurion intends to play an important role in the treatment of retinal disorders, including the successful development of THR-149, its novel therapeutic for the treatment of DME. THR-149 is a potent plasma kallikrein inhibitor being developed as a potential new standard of care for the up to 50% of DME patients showing suboptimal response to anti-VEGF therapy. Oxurion is headquartered in Leuven, Belgium, with corporate operations in Boston, MA. More information is available at www.oxurion.com.