KALAHARI phase 2, part B trial has completed randomization for participants with DME

Investigators have enrolled the 112 patients in the KALAHARI phase 2, part B clinical trial for diabetic macular edema (DME). This is above the originally planned total of 108 patients. (Image Credit: Adobe Stock/putilov_denis)

According to a press release¹ from the company, Oxurion has randomized the final patient in its KALAHARI phase 2, part B clinical trial for diabetic macular edema (DME). Investigators have enrolled the 112 patients in the trial. This is above the originally planned total of 108 patients.

With the completion of enrollment, Oxurion has confirmed its previous guidance that the company expects to report top-line data from the KALAHARI trial in Q4 of 2023.

According to the company, The KALAHARI trial is evaluating Oxurion’s novel plasma kallikrein (PKal) inhibitor THR-149 as a potential treatment for DME patients who respond suboptimally to anti-VEGF therapy.

The company describes THR-149 as a “bicyclic peptide that selectively inhibits human PKal with an inhibition constant of 0.22 nM. Through the inhibition of the kallikrein-kinin system (KKS), THR-149 prevents the induction of retinal vascular permeability, neurodegeneration, and inflammation.”

The Phase 2 KALAHARI trial is a two-part, randomized, prospective, multi-center trial assessing multiple (3) injections of THR-149 in DME patients. Part B is double-masked and actively controlled, with the high dose of THR-149 having been selected from Part A of the trial, according to the company.

Part A of the KALAHARI trial “demonstrated that all dose levels of THR-149 had a favorable safety profile,” according to the company. High-level data from Part A of the KALAHARI trial was first presented in October 2021, and “demonstrated that the 8 patients who received the highest dose of THR-149 achieved a mean BCVA gain of 6.1 letters at Month 3, the primary endpoint.”

The completion of enrollment follows the recommendation from an Independent Data Monitoring Committee (IDMC) in December 2022 that the KALAHARI trial should continue based on the outcome of a pre-specified futility analysis that included an evaluation of interim efficacy and safety data from 31 patients at the 3-month time point.

References:

1. Oxurion Finalizes Enrollment in KALAHARI Phase 2, Part B Trial of Novel PKal Inhibitor THR-149 in Diabetic Macular Edema. Press Release. Oxurion; June 12, 2023. Accessed June 12, 2023. https://www.globenewswire.com/news-release/2023/06/12/2685960/0/en/Oxurion-Finalizes-Enrollment-in-KALAHARI-Phase-2-Part-B-Trial-of-Novel-PKal-Inhibitor-THR-149-in-Dia