The death of Lady Sybil during childbirth in the BBC period drama ‘Downton Abbey’ highlighted the risky business of pregnancy caused by pre-eclampsia. Every minute a woman or a baby dies due to this devastating silent killer. Pre-eclampsia affects 1 in 12 pregnancies. The condition is characterized by high blood pressure, slow growth of the fetus and multiple organ failures, which if left unmanaged can lead to seizures, coma and death. There is no known way to prevent it and no single test to diagnose it. The only way to “cure” it is to deliver the baby. Currently, the most expensive nation in which to have a baby is the United States, where the average cost of an uncomplicated birth is $32,093. Complications like pre-eclampsia can increase this by 40 to 100 times. The Food and Drug Administration (FDA) cite pre-eclampsia detection and treatment as a significant unmet medical need. The FDA’s fast track process is designed to expedite the development and review of new drugs to address unmet medical needs of life-threatening conditions.
Large pharmaceutical companies make-up less than a quarter of drugs discovered. Deloitte’s report on life sciences states that small niche companies drive innovation and where the majority of new drugs are discovered. Birmingham is set to create a global capital of early stage pharmaceuticals in specific niche area of unmet medical needs. This is being spearheaded by companies like MirZyme Therapeutics, a spinout company by researchers at Aston University. The company is using a novel approach to bring new solutions to this life-threatening condition. The pioneering idea focuses on protective genes. MirZyme aims to ensure that every woman who chooses to have a baby has an opportunity to have a safe and healthy pregnancy. The goal therefore is to rapidly develop new and affordable medical therapies and diagnostics for global use with relative ease.
Despite decades of research the current management of pre-eclampsia still involves early delivery of the baby as continuing the pregnancy to fetal maturity threaten the life of the mother. Sadly, premature babies suffer from a myriad of complications, some of which can have a lasting lifelong impact including cerebral palsy, breathing difficulties and immunological problems to name a few. The rate of pre-eclampsia is on the rise, due in part, to more women giving birth at age 35 and above. The rise will continue as the new trends of “social egg freezing” and delaying “life events” such as getting married and starting a family goes global amongst working women. The demand for high quality healthcare plan for pregnancy will grow along with the expanding global middle class.
So, why has there been no successful treatment developed for pre-eclampsia? The cause of stagnation in pre-eclampsia drug development is largely because pre-eclampsia is a pregnancy-specific phenomenon and previous attempts to extrapolate the science of other major diseases to pre-eclampsia have failed. The researchers at Aston University took a different approach.
They focused on not what could cause preeclampsia but on what was preventing the majority of pregnant women from getting pre-eclampsia. They identified two protective pathways that put the ‘brakes’ on pre-eclampsia. This led these researchers to discover what’s in “the black-box” of pre-eclampsia. Finally, they discovered the roadmap of pre-eclampsia by ‘connecting the dots’. The team at MirZyme is developing a pipeline of treatments and a new diagnostic blood test that will allow doctors to diagnose pregnant women at risk. This test has the ability to diagnose 98 out 100 women destined to develop pre-eclampsia and this I believe will rapidly start to save lives and reduce costs by the end of this decade.
There are reasons to be optimistic. Science has taught us that early intervention approaches have the greatest opportunity to impact disease progression. I knew MirZyme was on the right track when the 345th Vice Chancellor of University of Cambridge and the former Chief Executive of Medical Research Council Professor Sir Leszek Borysiewicz wrote “I believe the direction in relation to the company [MirZyme] and pre-eclampsia is really exciting and could make a major difference in the future”.
In the last quarter of 2017, MirZyme Therapeutics acquired the rights to the knowhow and patents from Aston University. The company has completed the clinical testing of its diagnostic and the preclinical development of its therapies.
It is currently seeking Series B funding to move towards in-depth clinical development and commercialization. MirZyme will launch its diagnostic test in 2021, followed by a companion therapeutic in 2024.
Pipeline companies have high values when offering innovative products at clinical trials phase. For example AveXis was acquired by Novartis at an 88% premium of it’s initial share offering. Pipeline deals in 2018 included Novartis/AveXis – US$8.7b, Roche/Foundation Medicine – US$5.3b and Celgene/Juno Therapeutics – US$9b. These were single product companies whereas MirZyme has a pipeline of products at different stages of development and is entering a virgin market having already secured interest from a number of hospitals and healthcare providers.
Giving birth is linked to higher risk of heart disease and stroke compared to having no children. Yet most women choose to have babies, be it at a later age. MirZyme is gearing up to ensure that the roadmap to a healthy pregnancy is available to every woman by early diagnosis and preventing the progression of pre-eclampsia.
We require governments to encourage universities to support their regional startups like MirZyme who are addressing the unmet medical needs of Europe and beyond. I believe these companies will become the backbone of future economic growth.