Completed Patient Enrollment for Part A of Phase 2 INTEGRAL Trial Evaluating THR-687 for treatment of Diabetic Macular Edema (DME) in treatment naïve subjects
US IRB Approval of Protocol Amendment to Part B of the Phase 2 KALAHARI Trial Assessing THR-149 versus aflibercept for treatment of DME in patients that suboptimally respond to anti-VEGF therapy
Full dataset from Part A of KALAHARI Trial to be presented at Angiogenesis on February 12th
Leuven, BELGIUM,
THR-687 – Completed Patient Enrollment for Part A of the Phase 2 Clinical Trial (“INTEGRAL”) Evaluating THR-687 in Patients with DME
THR-687 is a potential best-in-class small molecule pan-RGD integrin antagonist being developed for the treatment of DME and holding promise for the treatment of wet Age-related Macular Degeneration (wAMD) and macular edema following Retinal Vein Occlusion (RVO). The INTEGRAL trial is a two-part Phase 2, randomized, multi-center clinical trial and is the first trial in which multiple intravitreal injections of THR-687 will be administered in humans.
“We are pleased to announce the completion of patient enrollment for Part A of the Phase 2 INTEGRAL trial of THR-687,”
Part A of the trial will assess two dose levels of multiple THR-687 injections and, if successful, the trial’s results will be used to select the appropriate dose for Part B of the INTEGRAL trial that will evaluate the efficacy and safety of THR-687 versus aflibercept (the current standard of care) for the treatment of DME. Part B of the trial will include both treatment experienced and treatment naïve subjects.
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.
THR-149 – Received Approval from the US
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.
The trial’s
- Enhance the probability of a successful trial outcome without impacting the trial timelines by refining the patient inclusion/exclusion criteria, and
- Provide preliminary data on the use of THR-149 before, or immediately following, anti-VEGF therapy by exploring synergies of THR-149 with aflibercept utilizing a cross-over style design with a fourth injection at month four
In
The post-hoc analysis of the Part A results identified opportunities to optimize the inclusion and exclusion criteria for Part B for both probability of success and speed. Part B of the KALAHARI trial is ongoing, assessing three monthly injections of THR-149, compared to three monthly injections of aflibercept, up to Month 3. As from Month 3, the safety and efficacy of a switched fourth injection (THR-149 to aflibercept or aflibercept to THR-149) will be evaluated in about half of the subjects whereas in the other half of the subjects the durability of three monthly injections (THR-149 or aflibercept) will be evaluated through a single sham injection. The trial is planned to randomize approximately 108 subjects in Part B and the primary endpoint remains the mean change in BCVA letter score from baseline, at Month 3.
Additional new data from Part A from the KALAHARI trial will be presented at Angiogenesis, Exudation, and Degeneration 2022, a virtual conference taking place
Final topline results from Part B the KALAHARI trial are expected by mid-2023.
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For further information please contact:
Chief Executive Officer Tel: +32 16 75 13 10 tom.graney@oxurion.com Chief Business Officer Tel: +32 479 783583 michael.dillen@oxurion.com | EU Tel: +44 203 928 6900 oxurion@medistrava.com US ICR Westwicke 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 wAMD 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 trial (dose selection), the Company has initiated Part B of the trial.
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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