Belgian biopharmaceutical company Oxurion has reported positive top-line data from a Phase I clinical trial of plasma kallikrein (PKal) inhibitor THR-149 in diabetic macular edema (DME) patients.

According to the results, THR-149 is safe and well-tolerated without any dose-limiting toxicities or drug-related serious adverse events at all dosages studied.

Developed in alliance with Bicycle Therapeutics, THR-149 is designed to inhibit the plasma kallikrein-kinin (PKaI-kinin) system.

The PKal pathway activation is known to trigger several of the DME disease markers, such as retinal vascular permeability, microaneurysm, and inflammation.

By inhibiting this pathway, THR-149 is expected to prevent the initiation of retinal vascular permeability, inflammation and angiogenesis.

In the open-label, multi-centre, non-randomised Phase I trial, the safety of a single intravitreal injection of the compound was assessed at three ascending dose levels in 12 patients with visual impairment due to center-involved DME.

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The study additionally evaluated THR-149’s efficacy including changes to the patient’s Best Corrected Visual Acuity (BCVA).

Trial data showed a rapid onset of action from day one and an increasing average BCVA improvement of up to 7.5 letters at day 14. This activity was sustained with an average BCVA improvement of 6.5 letters at day 90.

Oxurion CEO Patrik De Haes said: “We are delighted by these encouraging top-line data, which confirm that THR-149 is not only well-tolerated and safe for intravitreal use, but also provides a rapid and sustained gain in BCVA.

“These positive findings provide us with the information and confidence needed to plan the next stage of THR-149’s clinical development. They also demonstrate that THR-149 has the potential to become the best-in-class PKal inhibitor for the treatment of DME.”

Oxurion plans to present the complete Phase I data at Euretina in Paris and the American Academy of Ophthalmology (AAO) annual meeting in San Francisco later this year.