Oxurion NV (Euronext Brussels: OXUR) a biopharmaceutical company developing next generation standard of care ophthalmic therapies, with clinical stage assets in vascular retinal disorders, announced today that it has enrolled more than two-thirds of the planned total enrollment in its KALAHARI Phase 2, Part B clinical trial (KALAHARI trial). The KALAHARI trial is evaluating Oxurion’s novel plasma kallikrein (PKal) inhibitor THR-149 as a potential treatment for patients with diabetic macular edema (DME) who respond suboptimally to anti-VEGF therapy, the current standard of care.
Oxurion’s investigators have successfully recruited 80 of the 108 (74%) patients planned for this trial, for which Oxurion anticipates reporting top-line data in the fourth quarter of 2023. This milestone builds on the recommendation from an Independent Data Monitoring Committee (IDMC) in December 2022 that the KALAHARI trial should continue based upon the outcome of a pre-specified futility analysis that included an evaluation of interim efficacy and safety data from 31 patients at the three-month time point.
“We are very pleased with the pace of enrollment in the KALAHARI trial and appreciate the continued support of our investigators worldwide,” said Andy De Deene, MD, MBA, Chief Development Officer of Oxurion. “The outcome of this trial, which is evaluating THR-149 for the treatment of DME against the current standard of care, aflibercept, could, if positive, provide an important alternative for the up to 50% of patients with DME who respond suboptimally to current anti-VEGF therapies. We look forward to sharing the top-line results of the trial later this year.”
Oxurion also announced today that as a part of a planned transition, Dr. David Guyer and Dr. Adrienne Graves have resigned from the Company’s Board of Directors due to their other commitments, and will be replaced by Dr. Anat Loewenstein and Ms. Nathalie Laarakker.
Tom Graney, CFA, CEO of Oxurion, said, “We appreciate David and Adrienne’s contributions to Oxurion’s progress over the time they have served on the Board. While we regret that their professional responsibilities prevent their continued involvement, the Company and its programs have gained significantly from their insights and perspectives over the decade that they dedicated their time and expertise to our efforts to provide better treatment options for patients with retinal vascular diseases.”
Dr. Guyer stressed, “I’ve been so impressed by the dedication of the Oxurion team to advancing scientific innovations that could meaningfully improve therapeutic alternatives for millions of patients who suffer from DME and who respond suboptimally to current therapies.”
Dr. Graves added, “The market Oxurion is planning to address with THR-149 is greatly in need of the innovation that Oxurion is pursuing, and I’m grateful I had the opportunity to contribute to the company’s progress.”
Oxurion is delighted that Dr. Anat Loewenstein, Director of the Department of Ophthalmology at the Tel Aviv Medical Center, and Nathalie Laarakker, Chief Financial Officer at Intravacc B.V. in the Netherlands, have agreed to be co-opted as independent directors.
Dr. Loewenstein is a world leading retina specialist, and is the General Secretary of Euretina, President of the Israeli Ophthalmological Society, Sidney Fox Chair of Ophthalmology at Tel Aviv University, and Chairman of Ophthalmology at Sourasky Medical Center. She has also received numerous accolades for her cutting-edge work in retinal and macular disease, including Ophthalmology Power list: Top 100, Michelson Award of the Macula Society, the Rosenthal Award and the Macula Society’s Arnall Patz Medal for outstanding contribution in studies of retinal and macular diseases.
In addition to her experience as a CFO, Ms. Laarakker is a certified public accountant with more than 25 years of experience under IFRS, Dutch/US GAAP, and Sarbanes-Oxley in the Netherlands and the United States. In addition to her CPA from Royal NBA, Amsterdam, her education includes undergraduate and graduate degrees in auditing from the University of Amsterdam.
Mr. Graney said, “We are thrilled that Dr. Loewenstein and Ms. Laarakker have agreed to join the Oxurion board at this important time as we push towards completion of the KALAHARI trial for THR-149. We are confident that Dr. Loewenstein’s deep and intricate knowledge of retinal and macular diseases, combined with Ms. Laarakker’s financial and accounting acumen, will be invaluable as we complete the KALAHARI trial and beyond.”
The co-optation is subject to ratification by the Company’s Annual General Shareholders Meeting on May 2, 2023.