- THR-687 is a potent pan-RGD integrin antagonist holding potential as a next generation first line therapy for DME, currently a
$4.5 billion market opportunity
- THR-687 also holds promise for treatment of wet AMD (Age-related Macular Degeneration) and RVO (Retinal Vein Occlusion) thereby expanding the combined addressable annual market potential to
$12 billion
Leuven, BE,
The INTEGRAL study is a Phase 2, randomized, multicenter trial and is the first study in which multiple intravitreal injections of THR-687 will be administered in humans.
The two-part study will assess two dose levels of multiple THR-687 injections (Part A) and, if successful, go on to evaluate the efficacy and safety of THR-687 versus aflibercept (the current standard of care) for the treatment of DME (Part B).
Part A is being conducted in treatment naïve subjects to select the optimal THR-687 dose level to be assessed in Part B.
Part B will be conducted in both treatment naïve and treatment experienced subjects to evaluate the efficacy and safety of THR-687 compared to aflibercept.
The primary efficacy endpoint of the study in Part B is the change in Best Corrected Visual Acuity (BCVA) from baseline at Month 3.
The dose selection decision, following Part A, is anticipated in the first half of 2022 with top line data from Part B expected in the second half of 2023.
A single injection of THR-687 was safe and well-tolerated, showing a very encouraging efficacy signal. Across all doses, a rapid onset of action in mean BCVA was observed from Day 1 with an increase of 3.1 letters, which further improved to 9.2 letters at Month 1. The mean BCVA improvement was maintained with 8.3 letters gain at Month 3 following a single injection of THR-687.
A dose response was seen with the greatest positive effect on BCVA and Central Subfield Thickness (CST) with the highest dose of THR-687. For this highest dose, a mean BCVA improvement of 11 letters was noted at Day 14, with a peak improvement of 12.5 letters at Month 3. Similarly, a peak mean CST decrease of 106 µm was observed at Day 14 with the highest dose of THR-687.
Beyond DME, THR-687 has the potential to be developed for additional vascular retinal disorders including for wet Age-related Macular Degeneration (wet AMD) and Retinal Vein Occlusion (RVO).
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For further information please contact:
Chief Executive Officer Tel: +32 16 75 13 10 tom.graney@oxurion.com Chief Corporate Development Tel: +32 479 783583 Michael.dillen@oxurion.com | EU Tel: +44 20 7638 9571 oxurion@medistrava.com US Westwicke, an Christopher Brinzey Tel: +1 617 835 9304 chris.brinzey@westwicke.com |
About
- THR-687 is a highly selective pan-RGD integrin antagonist that is initially being developed as a potential first line therapy for DME patients. Positive topline results in a Phase 1 clinical study assessing THR-687 as a treatment for DME were announced in 2020.
Oxurion is currently conducting a Phase 2 clinical trial (“INTEGRAL”) evaluating THR-687 in patients with DME. THR-687 also has the potential to deliver improved treatment outcomes for patients with wet AMD and RVO.
- THR-149 is a potent plasma kallikrein inhibitor being developed as a potential new standard of care for the 40-50% of DME patients showing suboptimal response to anti-VEGF therapy. THR-149 has shown positive topline Phase 1 results for the treatment of DME. The company is currently conducting a Phase 2 clinical trial (“KALAHARI”) evaluating multiple injections of THR-149 in DME patients previously showing a suboptimal response to anti-VEGF therapy. Following positive data from Part A of this Phase 2 study (dose selection), the Company has initiated Part B of the study.
Important information about forward-looking statements
Certain statements in this press release may be considered “forward-looking”. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company’s Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of
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