Grants Patent Cancellation for Peptide Inhibitor of Plasma Kallikrein (PKal).
Leuven, BELGIUM, Boston, MA, USA – november 232022 – 5:00 PM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next-generation standard-of-care ophthalmic therapies with clinical-stage assets in vascular retinal disorders, today acquired Dyax Corp. s European patents 1 854 477 and 2 374 472. The European Board of Appeal announced its decision at a hearing on 15 November 2022.
With this latest decision, Oxurion further improves its intellectual property position on THR-149, a novel therapeutic for the treatment of diabetic macular edema (DME). Oxurion itself has patents issued for THR-149 until 2034, with the potential for an extension until 2039.
“We are pleased with the Appeals Board’s final decision dismissing Dyax’s claims,” said Tom Greney, CEO of Oxurion. “We are very proud of our work with THR-149, and the resolution of these claims will help Oxurion capture 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. By inhibiting 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 with a suboptimal response to anti-VEGF standard of care for the treatment of DME. DME is the leading cause of vision loss in the working-age population, and the treatment market is currently valued at $5+ billion. Results from an interim analysis of the KALAHARI Phase 2, Part B trial are expected by the end of 2022.
Part B of the KALAHARI study follows the successful Part A, where three dose levels of THR-149 (0.005 mg, 0.022 mg, and 0.13 mg) were each administered as a three-monthly IVT injection and subsequently evaluated to select this drug. the best dose for part B of the study.
High-level data from Part A of the KALAHARI trial were first reported in October 2021, demonstrating that eight patients receiving 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 a masked central reading center in February 2022 based on OCT (Optical Coherence Tomography) biomarker assessment.
The masked reading center identified two subjects with abnormalities likely to respond to any medical treatment. With the exception of these two subjects, a mean BCVA improvement of 9.3 letters was achieved at month 3, which was maintained until the end of the trial, month 6. Month 6 data also demonstrated an attractive safety profile of THR-149 and its ability to stabilize Central Site Thickness (CST). Data from Part A were incorporated into Part B through an adjusted study design, excluding patients who did 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 treatments designed to improve and better preserve vision in patients with retinal diseases, including diabetic macular edema (DME), a leading cause of vision loss at work. -elderly people as well as other conditions. Oxurion intends to play a significant role in the treatment of retinal diseases, including the successful development of THR-149, a 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 up to 50% of DME patients who respond suboptimal to anti-VEGF therapy. Oxurion is headquartered in Leuven, Belgium and has corporate operations in Boston, MA. More information is available at www.oxurion.com.
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