Press Release / Regulated Information / Inside Information
ThromboGenics - Patient Enrolment in Phase II CIRCLE Study
Evaluating THR-409 (ocriplasmin) for Non-Proliferative Diabetic Retinopathy (NPDR)
Discontinued due to Slow Recruitment Rate
Resources redirected to progress new drug candidates to clinic in H1 2018
Leuven, Belgium, – ThromboGenics NV (Euronext Brussels: THR), today announces that it has discontinued patient recruitment in its Phase II CIRCLE study for Non-Proliferative Diabetic Retinopathy (NPDR), effective immediately, due to the trial’s slow recruitment rate.
CIRCLE is a Phase II study evaluating the safety and efficacy of up to three intravitreal injections of THR-409 (ocriplasmin) to induce complete posterior vitreous detachment (total PVD) in NPDR patients, potentially avoiding disease progression from NPDR to proliferative diabetic retinopathy (PDR), a serious sight threatening condition.
Early symptoms of NPDR do not immediately affect a patient’s vision, therefore, many of the target patients for this study have few symptoms and so are less aware of their disease. These factors have contributed to the slow recruitment rate and the decision to discontinue study enrolment. Ocriplasmin was found to be generally safe and well-tolerated with no new safety signals raised.
Data from the study will be analyzed and shared with the scientific community via a publication in late 2018/early 2019. ThromboGenics will follow-up with every patient included in the study, as appropriate.
Resources previously earmarked for the CIRCLE study will be re-allocated to progress new drug candidates currently being explored for the treatment of diabetic eye disease into the clinic in 2018.
Patrik De Haes, MD, CEO of ThromboGenics, commented: “Our decision to terminate enrolment in the CIRCLE study is due to the slow recruitment rate, which is primarily due to the patients being unaware of their condition. We remain committed to developing novel therapies for the treatment of diabetic eye disease and look forward to using our redirected resources from this study to progress our current pipeline and to move an additional new drug candidate into the clinic in 2018.”