A new pill that could prevent pre-eclampsia has become the first pregnancy drug to be fast-tracked for development by the UK’s drug regulator.
Scientists at MirZyme Therapeutics, a biopharmaceutical company, believe they have developed a drug that when given to women from 20 weeks of pregnancy could stop them developing the condition.
Pre-eclampsia endangers the lives of thousands of expectant mothers and their babies in the UK each year, and has no therapeutic options. Globally, it affects between 2% and 8% of pregnancies and kills up to half a million babies and 100,000 women a year.
MirZyme Therapeutics has been awarded an innovative licensing and access pathway (ILAP), or so-called innovation passport, by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
The passport was established in January 2021 to expedite access to essential new drugs at the height of the Covid pandemic. It is granted to medicines that address the needs of patients with life-threatening and unmet medical needs, with a view to getting the drug to the market as quickly as possible.
MirZyme’s new drug, MZe786, is a single pill to be taken once a day by women deemed at risk of the condition, from the 20th week of pregnancy.
Pre-eclampsia is usually detected during the second half of pregnancy or soon after birth and can lead to serious complications if it is not found during midwife appointments. Early signs include high blood pressure and protein in the urine.
It is thought to stem from an overproduction of a molecule from the placenta, which results in damage to the blood vessels of the pregnant woman.
MirZyme claims to be the first company to develop products that can interfere with this molecule’s production, offering the possibility for women to be able to protect their babies and in some cases themselves from the condition.
When tested on mice, the drug was found effective in improving maternal and foetal outcomes, reducing blood pressure, preventing major organ damage in the expectant mother, improving foetal weight and decreasing foetal mortality. There were no detected negative side-effects on the mice or their offspring.
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The treatment will be offered to women who are identified in the early stages of pregnancy to be at a high risk of developing pre-eclampsia. MirZyme has also developed a diagnostic tool that it says can accurately detect pre-eclampsia in a pregnant woman prior to being symptomatic.
Prof Asif Ahmed, Mirzyme’s executive chair, said he was confident that the company would be able to recruit women for trials of the drug. He said: “If you get pre-eclampsia, it’s so devastating that women are prepared to take medication. We want to give pregnant women choices and we have a string of other drugs in the pipeline.”
An MHRA spokesperson said: “The ambition of this new licensing and access pathway is to reduce the time to market for innovative medicines. The ILAP combines the MHRA’s globally recognised strengths of independence and high standards of quality, safety, and efficacy, with improved efficiency and flexibility, readying the MHRA for a new era in medicines approvals in the UK.”