Scientists at MirZyme Therapeutics, a biopharmaceutical company, believe they have developed a drug that when given to women from the 20th week of pregnancy could prevent them from developing the condition. Pre-eclampsia puts the lives of thousands of mothers-to-be and their babies at risk in the UK every year and has no treatment options. Globally, it affects between 2% and 8% of pregnancies and kills up to half a million babies and 100,000 women annually. MirZyme Therapeutics has received an Innovative Licensing and Access Pathway (ILAP), or so-called innovation passport, from the UK Medicines and Healthcare products Regulatory Agency (MHRA). The passport was introduced in January 2021 to speed up access to essential new medicines at the height of the Covid pandemic. It is given to drugs that meet the needs of patients with life-threatening and unmet medical needs, with the goal of bringing the drug to market as soon as possible. MirZyme’s new drug, MZe786, is a single pill to be taken once a day by women considered to be at risk for 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 not detected during midwife appointments. Early signs include high blood pressure and protein in the urine. It is thought to come from overproduction of the molecule by the placenta, which results in damage to the pregnant woman’s blood vessels. MirZyme claims to be the first company to develop products that can interfere with the production of this molecule, enabling women to protect their babies and in some cases themselves from the condition. When tested in mice, the drug was found to be effective in improving maternal and fetal outcomes, lowering blood pressure, preventing severe organ damage in the expectant mother, improving fetal weight and reducing fetal mortality. No negative side effects were detected in the mice or their offspring. Archie Bland and Nimo Omer take you to the top stories and what they mean, free every weekday morning Privacy Notice: Newsletters may contain information about charities, online advertising and content sponsored by external parties. For more information, see our Privacy Policy. We use Google reCaptcha to protect our website and Google’s Privacy Policy and Terms of Service apply. The treatment will be offered to women who are found to be at high risk of developing pre-eclampsia in the early stages of pregnancy. MirZyme has also developed a diagnostic tool that it says can accurately detect preeclampsia in a pregnant woman before she becomes symptomatic. Professor Asif Ahmed, executive chairman of Mirzyme, said he was confident the company would be able to recruit women for trials of the drug. She said: “If you get pre-eclampsia it is so devastating that women are ready to take medication. We want to give pregnant women options and we have a number of other drugs in the pipeline.” An MHRA spokesman said: “The ambition of this new authorization and access route is to reduce the time to market for innovative medicines. ILAP combines the MHRA’s globally recognized strengths of independence and high standards of quality, safety and effectiveness, with improved efficiency and flexibility, preparing the MHRA for a new era in UK drug approvals.
