Oxurion NV’s proposed drug for diabetic macular edema failed to demonstrate efficacy on key endpoints based on top line results from its Phase II trial.
Oxurion NV‘s proposed drug for diabetic macular edema failed to demonstrate efficacy on key endpoints based on top-line results from its Phase II trial. Because of the unfavorable efficacy outcome, Oxurion said it is not advancing to Part B of its study.
Data from Part A of its two-part Phase II Integral study showed THR-687 to be well tolerated and safe, with no adverse events through three months, but it was not able to show evidence of efficacy in terms of Best Corrected Visual Acuity (BCVA) and Central Subfield Thickness (CST) scores.
Part A endpoints were safety and efficacy, with two dose levels of 1.2 mg and 2.0 mg given in three monthly injections via IVT.
“While we had hoped for a better outcome for the patients in the Integral trial, we remain committed to developing new treatments to address the substantial unmet needs that remain in retinal diseases. As we discontinue our development of THR-687, we will explore potential partnership opportunities for the asset. Additionally, we are undertaking a thorough review of our capital and resource allocation plans to ensure that they are aligned with our objective of maximizing value creation for all stakeholders,” Oxurion CEO Tom Graney, CFA said in a statement.
The Belgium-headquartered firm, which has a corporate office in Boston, Massachusetts, is now focusing its attention and resources on THR-149, a plasma kallikrein inhibitor, to address the needs of DME patients.
THR-149 demonstrated strong efficacy and safety results in Part A of a two-part Phase II Kalahari trial. Oxurion is enrolling participants for Part B of its study in Europe and the U.S. The drug is being developed to potentially become the new standard of care for up to 50% of DME patients who respond poorly to anti-VEGF therapy.
Oxurion shared high-level Part A results in February 2022, showing a mean BCVA gain of 6.1 letters in the third month in the eight DME participants. Other key endpoints were CST and Optical Coherence Tomography (OCT) scores. Based on Part A outcomes, the researchers decided to push forward to Part B using the high dose of THR-149 to compare with aflibercept.
The THR-149 study, which will include around 108 subjects, is ongoing and is expected to come out with topline data by mid-2023. The primary endpoint remains the mean change in the BCVA letter score from baseline.
“Novel mechanisms, like THR-687 and THR-149, remain an important opportunity to address the significant unmet medical needs for our patients with DME. Following the impressive data presented at Angiogenesis this year from the Phase 2 Part A KALAHARI trial forTHR-149 in DME, I am looking forward to seeing the Part B data expected next year,” Arshad M. Khanani, MD, MA, the director of clinical research at Sierra Eye Associates in Reno, Nevada, said.
