Oxurion has reported top-line results from the Phase IIa clinical trial of THR-317 in combination with ranibizumab to treat diabetic macular edema (DME) patients.
THR-317 is a humanised antibody targeting placental growth factor (PlGF), while ranibizumab is an anti-vascular endothelial growth factor (VEGF) antibody.
The randomised, single-masked, active-controlled, multi-centre Phase IIa trial assessed the safety and efficacy of three monthly intravitreal injections of the combination in a total of 70 subjects with centre-involved DME.
Ranibizumab plus sham was used as a control during the exploratory proof-of-concept study. The primary endpoint was efficacy measured as the patient’s Best Corrected Visual Acuity (BCVA).
Data showed no improvement in mean BCVA with the THR-317 combination compared to ranibizumab monotherapy at month three in the overall population.
Investigators also used the Early Treatment of Diabetic Retinopathy Study (ETDRS) standardised eye chart, which showed an increase of 8.71 letters in patients treated with the combination versus 8.18 letters in those on the monotherapy treatment.
In addition, THR-317 plus ranibizumab led to some improvement at month three in BCVA in subjects with poor or no response to previous anti-VEGF therapy.
This population achieved a mean increase of 8.08 letters for the combination compared to an increase of 6.43 letters with ranibizumab alone.
Also, participants who had baseline BCVA of less than or equal to 65 letters saw a mean increase of 11.14 letters with the combination therapy versus an increase of 8.88 letters for monotherapy.
Oxurion CEO Patrik De Haes said: “The top-line results from this exploratory Phase II study indicate that THR-317 in combination with ranibizumab could play a role in the treatment of poor (or no) response to prior anti-VEGF and with patients with a baseline BCVA of less or equal to 65 letters.
“We will continue to review and analyse these data before deciding on how to best position this programme as we progress our clinical-stage portfolio of next-generation therapies for the treatment of DME.”
According to the results, the combination was safe and well-tolerated without any drug-related ocular serious adverse events.