Bicycle Therapeutics, a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that the first patient has been dosed in Oxurion’s Phase II study of THR-149, a novel Bicycle-based plasma kallikrein (PKal) inhibitor, in patients with diabetic macular edema (DME).
“Bicycles are a new modality with unique properties that provide a differentiated approach for the treatment of a wide range of diseases, which we are exploring through our strategic partnerships with therapeutic specialists such as Oxurion,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “In addition to positive safety and tolerability results, during the Phase I trial of THR-149, investigators observed that patients experienced a sustained improvement in best corrected visual acuity for 90 days following a single administration of THR-149. In the Phase II study, we hope to learn more about the potential utility of Bicycles in treating DME, an ophthalmic condition for which there is an urgent need for additional medicines.”
“An estimated 40% of patients with DME do not respond optimally to anti-VEGF monotherapy, which is the standard of care,” said Patrik De Haes, M.D., Chief Executive Officer of Oxurion. “Given the high unmet need in this patient population and the positive Phase I safety and tolerability data, we believe THR-149 could provide an important new mechanism of action for treating patients with this debilitating disease. We look forward to building on the Phase I results as we advance THR-149 into this next stage of clinical development.”
The Phase II trial, named KALAHARI, is expected to include approximately 122 patients with central involved DME who do not respond adequately to anti-VEGF and will be comprised of two parts. Part A (n=18) is a dose-ranging study in which three dose levels, including multiple administrations of THR-149, will be evaluated. The primary objective of Part A is to identify the optimal dose to be used in Part B of the trial. Part B (n≈104) is a double-blind active control study that will evaluate the efficacy of THR-149 at the dose level selected in Part A versus the comparator aflibercept.
Article sourced from Business Wire