Right now there’s no cure for pre-eclampsia. The only treatment is to deliver the baby early. In severe cases, the effects of pre-eclampsia occur early in pregnancy which affects the babies as well.
“In fact, pre-eclampsia causes around 15 per cent of all premature births worldwide,” explains Professor Stefan Hansson, A1M Pharma’s chief clinician.
“This is a big cost. Premature born babies are under-developed, and 25 per cent of pre-eclamptic babies are growth restricted – a serious condition where the baby’s growth is severely restricted in the womb, leading to increased vulnerability and also long-term consequences such as increased risk for cardio-vascular diseases.”
There are also long-term risks for the mother, with significantly higher risk of heart disease, stroke and type II diabetes.
Considering that both the acute and long-term risks are so high for mother and child, A1M Pharma is eager to develop a treatment for pre-eclampsia so that the pregnancy can continue for longer reducing prematurity, as well as protecting the mother’s organ to prevent disease complications and long-term consequences.
A natural treatment
In pre-eclampsia, our scientists found that extra haemoglobin – a part of the blood that carries oxygen – and molecules called ‘oxygen radicals’ accumulate in the placenta, causing it to be less functional and release toxic substances.
These leak from the placenta into the mother’s blood where blood vessel and kidney damage is induced. This results in the high blood pressure and protein in the urine that characterises pre-eclampsia.
Our scientists also found that the alpha-1-microglobulin (A1M) protein is naturally found in high levels around the damaged placenta and kidneys in pre-eclampsia. As we’ve written before, this is because the body produces extra A1M protein in response to high levels of damage caused by oxygen radicals and the toxic hemoglobin degradation product haem, attacking the body.
“A1M is a natural protein we have in our bodies. It’s found in the blood, the fluid that surrounds our cells and in the cells themselves,” says Professor Bo Åkerström, A1M Pharma’s chief scientist.
“The A1M protein is shaped like a bucket and scoops up small molecules that cause damage to the body, like the oxygen radicals and haem groups that are produced in pre-eclampsia.”
Because of the protein’s natural role in countering the damage behind pre-eclampsia, we’re hopeful that it will provide an effective, natural treatment to overcome the condition mimicking nature’s own mechanisms.
As Professor Åkerström explains “We think it not only scoops up the haem groups and oxygen radical molecules, but also can reverse the damage done by them in the placenta, blood vessels and kidneys. What we want to do is give mothers with pre-eclampsia even more A1M protein.”
Next steps for developing the A1M protein
After years of research we’ve now developed a new version of the A1M protein, called RMC-035 or ROSgard™. This is as effective as the body’s natural A1M protein and mimics how it works, while being easy to produce and suitable for use around the world in lots of different healthcare conditions.
The next stage of developing the drug will involve pre-clinical testing and then further clinical trials in healthy volunteers to evaluate safety.
Once this is complete, ROSgard will go through rigorous clinical testing, firstly in a phase I trialin a small group of healthy volunteers. It will then go into a phase II trial in a small group of women with pre-eclampsia. Here scientists will study how effective the drug is at treating the damage done to the mother’s kidneys, blood vessels and placenta by pre-eclampsia.
By improving the mother’s and baby’s health in this way A1M Pharma could produce the world’s first pharmacological treatment for pre-eclampsia thereby taking a step closer to benefitting mothers and babies worldwide.