Oxurion NV is preparing to file for bankruptcy following the release of topline phase 2 data from the KALAHARI part b study, which found its novel therapy THR-149 did not demonstrate improved vision in diabetic macular edema (DME) study participants.
Let’s start with this company.
Headquartered in Leuven, Belgium, with corporate operations located in Boston, Massachusetts, the biopharmaceutical company has been focused on developing next-generation therapeutics for retinal disorders such as DME.
Its lead therapy was THR-149.
Which is…
THR-149 is a bicyclic peptide that selectively inhibits human plasma kallikrein (PKal) with an inhibition constant of 0.22 nM.
The therapy uses the kallikrein-kinin system (KKS)—which regulates physiological processes and is involved in cardiovascular and renal regulation—to potentially block the induction of retinal vascular permeability, neurodegeneration, and inflammation.
And this trial?
The phase 2 KALAHARI trial (not to be confused with Bausch + Lomb’s KALAHARI extension trial for MIEBO) was a two-part, randomized, prospective, multicenter, study (NCT04527107) examining intravitreal injections of THR-149 at three dose levels vs aflibercept and sham in DME patients.
To note, all participants were required to have responded suboptimally to anti-vascular endothelial growth factor (anti-VEGF).
So what happened in part A?
THR-149 at all dose levels demonstrated a favorable safety profile, with mild to moderate ocular adverse events (no severe), no inflammation, and an ability to stabilize central subfield thickness (CST), according to the company.
In support of the study’s primary endpoint, six patients administered the highest THR-149 dose achieved a 9.3-letter mean best-corrected visual acuity (BCVA) gain at Month 3, which was sustained through Month 6 and 4 months following the last injection.
And in part B?
Part B, which enrolled 112 patients, was double-masked and actively controlled with a high dose of THR-149 selected from part A (vs aflibercept).
So what happened?
Per the company, part B did not meet its primary endpoint, with the mean change in BCVA (from baseline to Month 3) being -0.2 letters for the THR-149 arm (vs +2.5 letters for the aflibercept arm).
However, the data “confirmed that THR-149 was safe and well tolerated,” according to Oxurion.
And this is the reason for bankruptcy?
In part, yes. The other is due to Oxurion’s low cash position, the company stated.
Also keep in mind: this latest DME study failure follows two other DME therapies that were previously discontinued:
- THR-317 → an anti-PIGF antibody that failed in 2019
- THR-687 → a pan RGD integrin antagonist that failed in 2022.
Is there a timeline for this yet?
Nope, not as of Nov. 20, 2023.