Oxurion Nv · EURONEXT:OXUR

Oxurion Nv — FLORetina 2019

16 slides from Oxurion Nv's conference presentation, June 2019

  1. Slide 1: Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Edema

    THR-317-001: Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Edema Anat Loewenstein Tel Aviv Medical Center FLORetina June 2019

  2. Slide 2: THR-317: A Humanized mAb Against Human PlGF

    THR-317: A Humanized mAb Against Human PlGF1,2 • Anti PLFG reduces NV & leakage in a mouse model of CNV, comparable to VEGF inhibition • Additional benefits may be activation of protective factors decreasing inflammation and pericyte loss with preservation of the BRB as well as inhibition of fibrosi

  3. Slide 3: Two-Stage Study Design

    THR-317-001: Two-Stage Study Design Primary endpoint: Incidence of acute (up to the Day 7 post-injection visit) ocular (serious) adverse events in the study eye, after each injection and across injections per subject Treatment population Stage 1 • Adults with center- Non-randomized, THR-317 4 mg (n=

  4. Slide 4: Key Inclusion/Exclusion Criteria (study eye)

    THR-317-001: Key Inclusion/Exclusion Criteria (study eye) Inclusion • Center-involved DME with CST ≥340 µm on Spectralis SD-OCT or ≥320 µm on non-Spectralis SD-OCT assessed by reading center • BCVA ETDRS letter score between 72 and 23 letters (20/40 and 20/320 Snellen equivalent) • NPDR or stable PD

  5. Slide 5: Demographics

    THR-317-001: Demographics All Treated Subjects, by Prior Anti-VEGF Treatment Status THR-317 4 mg THR-317 8 mg Anti-VEGF Anti-VEGF poor Overall Anti-VEGF Anti-VEGF poor Overall treatment naïve responder treatment naïve responder Characteristic N=20 N=4 N=24 N=20 N=5 N=25 Gender, n (%) Male 9 (45.0) 3

  6. Slide 6: Baseline BCVA and CST in the Study Eye

    THR-317-001: Baseline BCVA and CST in the Study Eye All Treated Subjects, by Prior Anti-VEGF Treatment Status THR-317 4 mg THR-317 8 mg Anti-VEGF Anti-VEGF poor Overall Anti-VEGF Anti-VEGF poor Overall treatment naïve responder treatment naïve responder Characteristic N=20 N=4 N=24 N=20 N=5 N=25 BCV

  7. Slide 7: Safety Overview

    THR-317-001: Safety Overview All Treated Subjects THR-317 4 mg THR-317 8 mg N=24 N=25 Category n (%) n (%) Deaths 0 (0.0) 0 (0.0) SAE Any ocular SAE 0 (0.0) 0 (0.0) Any nonocular SAEa 1 (4.2) 0 (0.0) AE leading to withdrawal from study 0 (0.0) 0 (0.0) AE leading to withdrawal from repeat injection 0

  8. Slide 8: Summary of Adverse Events (1/2)

    THR-317-001: Summary of Adverse Events (1/2) All Treated Subjects THR-317 4 mg THR-317 8 mg N=24 N=25 Category n (%) n (%) Overall Any AE 9 (37.5) 11 (44.0) Any AE in study eye 5 (20.8) 7 (28.0) Any AE in nonstudy eye 2 (8.3) 1 (4.0) Any nonocular AE 6 (25.0) 5 (20.0) • Overall incidence of AEs simi

  9. Slide 9: Acute Adverse Events in the Study Eye

    THR-317-001: Acute (Up to Day 7 PI) Adverse Events in the Study Eye All Treated Subjects THR-317 4 mg THR-317 8 mg Across injections Across injections N=24 N=25 Adverse event n (%) n (%) 3 subjects, 3 events 4 subjects, 4 events Conjunctival hemorrhage 1 (4.2) 1a (4.0) Ocular hyperemia 0 (0.0) 1a (4

  10. Slide 10: Mean Change in BCVA From Baseline

    THR-317-001: Mean Change in BCVA From Baseline All Treated Subjects THR-317 4 mg (N=24) THR-317 8 mg (N=25) 15 Mean change (95% CI) from Baseline (ETDRS letters) 10 5 0 BL PI M1 PI M2 PI M3 M5 1 month after last 3 months after last injection injection Study visit (months) • Increase in mean BCVA sho

  11. Slide 11: Mean Change in BCVA From Baseline by Subgroup

    THR-317-001: Mean Change in BCVA From Baseline Anti-VEGF treatment naïve Anti-VEGF poor responders THR-317 4 mg (N=20) THR-317 8 mg (N=20) THR-317 4 mg (N=4) THR-317 8 mg (N=5) 15 18.4 15 17.7 Mean change (95% CI) from Mean change (95% CI) from Baseline (ETDRS letters) Baseline (ETDRS letters) 10 10

  12. Slide 12: BCVA Line Gain: Anti-VEGF Treatment Naïve Subjects

    THR-317-001: BCVA Line Gain at Month 3 and Month 5 Anti-VEGF Treatment Naïve Subjects BCVA ≥3 lines gain 100 BCVA ≥2 lines gain 100 Proportion of subjects, % (95% CI) (or ≥ 83 ETDRS letters) Proportion of subjects, % (95% CI) 90 THR-317 4 mg (N=19) THR-317 8 mg (N=20) THR-317 4 mg (N=19) THR-317 8 m

  13. Slide 13: BCVA Line Gain: Anti-VEGF Poor Responders

    THR-317-001: BCVA Line Gain at Month 3 and Month 5 Anti-VEGF Treatment Poor Responders ≥2 Line Gainers • 4 mg arm: 0/4 (0%) at Month 3 and at Month 5 • 8 mg arm: 1/5 (20%) at Month 3 and 1/5 (20%) at Month 5 ≥3 Line Gainers • 4 mg arm: 0/4 (0%) at Month 3 and at Month 5 • 8 mg arm: 1/5 (20%) at Mont

  14. Slide 14: Mean Change in CST From Baseline

    THR-317-001: Mean Change in CST From Baseline Anti-VEGF treatment naïve Anti-VEGF poor responders THR-317 4 mg (N=20) THR-317 8 mg (N=20) THR-317 4 mg (N=4) THR-317 8 mg (N=5) 100 100 108.7 147.6 124.8 Mean (95% CI) change in CST Mean (95% CI) change in CST 50 50 from Baseline (µm) from Baseline (µm

  15. Slide 15: THR-317-001 Conclusions

    THR-317-001 Conclusions • 3 monthly intravitreal injections of THR-317 4 mg and THR-317 8 mg were generally safe and well tolerated • Limited number of AEs, all acute AEs in the study eye were mild in severity and resolved within 1 to 31 days of onset • Visual gains in both the THR-317 4 mg and 8 mg

  16. Slide 16: Thank you 317-001 Patients and Investigators

    Thank you 317-001 Patients and Investigators Czech Republic Slovakia Hungary • In total, 49 subjects were treated at 12 sites in Czech Republic, Slovakia and Hungary

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