Secures Revocation of Patent for Peptide Inhibitor of Plasma Kallikrein (PKal)
Leuven,
With this final decision,
“We are pleased with the Appeal Board’s final decision revoking the
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
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
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Attachment
- OXUR Patent Prevails 2022.1123 FINAL
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