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We are developing a rhC1INH protein replacement therapy for the treatment of pre-eclampsia. Pre-eclampsia is a life-threatening multisystem disorder in pregnancies leading to maternal and neonatal mortality and morbidity, usually first detected by hypertension. Proteinuria is a common symptom. Abnormal or impaired spiral artery development between the mother and the fetus may be responsible, which may trigger the complement cascade when these spiral arteries come under stress, especially oxidative stress because of poor blood flow.

Pre-eclampsia

Treatments include termination of the fetus or very premature birth, which is often associated with very high rates of mortality. Palliative care of the PE-damaged mother and neonatal care of premature babies can drive the costs of pre-eclampsia patients very high. Even if they can be born safely, consequences for the child can be severe, with growth restrictions, learning difficulties and moderate to severe disabilities affecting over half of such newborns.

Almost 2.5 million cases of pre-eclampsia are reported annually, with rates running at between 3% and 10% of all pregnancies in developed countries. In the United States alone, estimated annual cases of pre-eclampsia exceed 120,000. The outcome for both mother and baby can be severe. Each year, 50,000 maternal deaths are recorded for patients who proceed to full-blown eclampsia, while many more are caused by long-term irreversible damage to organs caused by pre-eclampsia while the mother carries her child before birth.

As shown in the table below, a study of C1INH levels in pregnant women have demonstrated that such women have reduced circulating C1INH levels.

We believe that protein replacement therapy with rhC1INH may slow the rate of progress of the condition and thereby reduce the level of damage that it can cause to mother and the unborn baby.

We are conducting an open label, single-arm, multi-stage, multi-center Phase 1/2 study in late-stage pre-eclampsia in the Netherlands and Australia. The study will initially be conducted to assess the tolerability and safety of treatment with RUCONEST® in 30 patients with mid- to late-stage symptomatic pre-eclampsia.

This study was initiated in 2019, but was halted due to COVID-19.

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