Oxurion Nv · EURONEXT:OXUR
Oxurion Nv — Technical Presentation (June 2022)
12 slides from Oxurion Nv's technical presentation, Jun 7, 2022
Slide 1: THR-687, a Potent and Highly Selective RGD Integrin Inhibitor in Development for DME
THR-687, a Potent and Highly Selective RGD Integrin Inhibitor in Development for the Treatment of DME Francesco Bandello Co-authors: Hani Salehi-Had, Erik F Kruger, Veeral Sheth, Payam Amini
Slide 2: Disclosure
Disclosure • ALLERGAN • BAYER • BOEHRINGER-INGELHEIM • FIDIA SOOFT • HOFMANN LA ROCHE • NOVARTIS • NTC PHARMA • SIFI • OXURION • ZEISS 2
Slide 3: Selective RGD Integrin Antagonist | THR-687
Selective RGD Integrin Antagonist | THR-687 Small molecule targeting a broad spectrum of disease hallmarks of DR/DME, nAMD and ME-RVO • In the eye, integrins have been shown to play an important role in neovascularization, vascular permeability, inflammation, fibrosis, and gliosis • By selectively a
Slide 4: THR-687 Phase 1 Clinical evidence
THR-687 Phase 1 Clinical evidence Safety and efficacy after one single injection of THR-687 • THR-687 was safe and well-tolerated | No dose limiting toxicities, no serious adverse events occurred in the study • All treatment-related adverse events were unrelated to THR-687 • Three subjects receive
Slide 5: THR-687 Phase 2 Part A Clinical Trial in DME
THR-687 Phase 2 Part A Clinical Trial in DME Primary Endpoint was BCVA Secondary Endpoints include CST, AEs Part A Dose level selection THR-687 N≈12, rando 1:1 1.2mg 2.0mg Phase 2 Part A • Dose selection for Part B Treatment-naïve • First time multiple IVT of THR-687 in treatment DME patients:
Slide 6: Demographics
Demographics • Follow-up of patients to Month 6 is still Overall Overall ongoing All Treated Set Per Protocol set • Only summary data are Characteristic N=16 N=14 presented to protect Gender, n (%) the credibility of Male 9 (56) 9 (64) further data collection Female 7 (44) 5 (36) Race, n (%) Asian 2
Slide 7: Baseline Ocular Characteristics in the Study Eye
Baseline Ocular Characteristics in the Study Eye *DR severity level had to be severe NPDR or lower (ETDRS level <61) per the protocol eligibility criteria, ** Time since diagnosis of DME had to be less than 1 year prior to screening as per the protocol inclusion criteria. Abbreviations: DME, Diabeti
Slide 8: Mean Change in BCVA and CST from Baseline
Mean Change in BCVA and CST from Baseline a Per Protocol Set and All Treated Set a Missing values replaced by LOCF approach; no rescue treatment was administered. BCVA, Best-corrected Visual Acuity; BL, Baseline; ETDRS, Early Treatment Diabetic Retinopathy Study; LOCF, Last Observation Carried Forwa
Slide 9: Summary of Adverse Events: up to Month 3 (1/2)
Summary of Adverse Events: up to Month 3 (1/2) All Treated Set Overall N=16 Category n [E] Overall Any AE 8 [12] Any AE in Study eye 5 [6] Any AE in Non-Study eye 0 Any Non-Ocular AE 5 [6] AEs Related to IMP Any AE 1 [1] Any AE in Study eye 1 [1] AEs Related to Injection Procedure Any AE 0 SAEs Any
Slide 10: Adverse Events in the Study Eye: up to Month 3
Adverse Events in the Study Eye: up to Month 3 All Treated Set Overall N=16 Adverse event n [E] Optic Disc Hemorrhage 1 [1] Retinal Thickening 2 [2]* Visual Acuity Reduced 3 [3] No IOI, endophthalmitis, vasculitis or vascular occlusion occurred. * One of them related to IMP (no AEs were considered R
Slide 11: Overall Conclusions
Overall Conclusions Study population • Study population was representative of treatment naïve DME patients based on the CRC feedback on OCT at BL • Mean BL BCVA and CST values were aligned with naïve DME studies for other compounds Efficacy • There was insufficient evidence of efficacy on the key en
Slide 12: Currently enrolling
• ’s other asset THR-149 is in Phase 2 Currently • The Part B of the global enrolling trial in DME patients with suboptimal response to aVEGF is ongoing. Topline results: Mid 2023 12