Studies suggest that ROSgard could be used as a drug to treat toxaemia in pregnancy (also called pre-eclampsia) – a potentially fatal condition that affects around ten million pregnant women each year, and for which there is currently no curative treatment.

Successful clinical trials
Stefan Hansson’s and Bo Åkerström’s research groups at Lund University have been able to show that free fetal hemoglobin collects in the placenta during pre-eclampsia, from where it leaks into the mother’s blood circulation. Free hemoglobin causes oxidative stress, which in turn has a harmful effect on all cells in the body. In recent years, researchers have conducted a number of successful therapeutic studies using ROSgard in animal models for pre-eclampsia.
  • In the laboratory model, where a human placenta is kept alive outside the uterus by pumping a nutrient solution and oxygen through its vessels, pre-eclampsia could be induced by introducing high levels of free fetal hemoglobin. The placental damage that occurred was identical to the damage observed in pregnant women suffering from pre-eclampsia. Intravenous treatment could be simulated by adding ROSgard to the perfused placenta.
Images from the aforementioned study on healthy tissue:
Treatment with A1M
 (A) Healthy placenta (B) Placenta with pre-eclampsia (C) After treatment with ROSgard
  • All the studies have consistently shown that ROSgard helps to prevent and repair damage to placentas and kidneys. None of the treated animals suffered any side effects. The results provide good hope that ROSgard may be the first preventive and therapeutic drug for pre-eclampsia.

The way forward

Planning work prior to the clinical phase for treatment of pre-eclampsia will be coordinated with the clinical trials into kidney protection in connection with radiation therapy, because the kidneys are key organs in both conditions. Among other things, discussions will be held with regulatory authorities on the possibility of immediately implementing a Phase II trial based on data from clinical trials into kidney protection in connection with radiation therapy. Regarding the new clinical programme, we also plan to develop a diagnostic solution for individual adaptation of pre-eclampsia treatment by measuring the harmful substances, including free fetal hemoglobin, also known as companion diagnostics. Our aim is to out-license the diagnostic method and the treatment method together in order to maximise the value for our shareholders. The principal scenario is a licensing deal after clinical Phase II, but any opportunity for an earlier licensing deal will be evaluated based on what is most beneficial to the company’s development. For more information, see the timetable. For more information, see the timetable.

Pregnant – with lives at stake

Toxaemia in pregnancy, more commonly known as pre-eclampsia, is a medical condition that arises during pregnancy. Today, the condition is diagnosed if a woman’s blood pressure is too high and protein is detected in the urine after the twentieth week of pregnancy. The symptoms are often vague, but some typical symptoms are swelling and headaches. In its most severe form, pre-eclampsia can develop into eclampsia – a life-threatening condition characterised by epilepsy-like seizures and general organ failure. In Sweden, approximately 5,000 pregnant women are diagnosed with pre-eclampsia each year, corresponding to 3-7% of all pregnant women. Since the only cure today is to terminate the pregnancy, pre-eclampsia also causes 15% of all premature births.

Pre-eclampsia

Complications and death from pre-eclampsia are rare in Sweden, but globally pre-eclampsia is a medical problem of immense proportions; it causes 76,000 deaths among pregnant women worldwide, – that's one death every seven minutes. There is currently no reliable method of identifying patients who are at risk of developing the condition early on in pregnancy, and after week 20 of pregnancy current diagnostic methods rely heavily on blood pressure monitoring, which is not sufficiently specific to be reliable. Today, only symptomatic treatment is available, which primarily aims to reduce blood pressure. The only curative treatment for pre-eclampsia is to end the pregnancy by inducing labour and delivery.

Pre-eclampsia affects the woman’s kidneys
Pre-eclampsia is a condition that affects all of the pregnant woman’s organs, especially the kidneys. During pregnancy the kidneys must adapt to a changed hormone profile, an increased metabolism, and a greater volume of blood. Therefore, conditions that affect the kidneys, such as diabetes and systemic lupus erythematosus (SLE), can also increase the risk of pre-eclampsia. In addition, there is a clear link between kidney disease – even mild cases – and pre-eclampsia.

The reasons why some women develop pre-eclampsia are still unknown, which is why the condition is also called “the disease of theories”. The first step in the development of the disease is due to the placenta not having developed correctly. This leads to an inadequate blood supply, which causes oxidative stress, which in turn damages the placenta. During the initial stage of the disease, there is a build-up of free fetal hemoglobin, the degradation products of which are toxic, and this causes inflammation and vascular damage. The second stage of the disease sees these toxic substances leaking into the mother’s blood circulation. The clinical symptoms appear late in pregnancy and can quickly develop into potentially fatal conditions, in particular swelling of the brain and the onset of eclampsia.

Clinical manifestations and symptoms:
- high blood pressure
- proteinuria (protein in urine)
- leaking blood vessels, which cause swelling
- abdominal pains, headaches, visual disturbances
- seizures and stroke

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