MIRZYME AWARDED THE FIRST FAST-TRACK INNOVATION PASSPORT FOR THE TREATMENT OF PREECLAMPSIA
MIRZYME THERAPEUTICS AWARDED THE FIRST FAST-TRACK INNOVATION PASSPORT FOR THE TREATMENT OF PREECLAMPSIA FROM THE MHRA, THE UK REGULATOR
MZe786, a new drug to prevent preeclampsia, is the first drug in pregnancy to be awarded an Innovation Passport from the MHRA for the treatment of preeclampsia1 and is being evaluated in several disorders of pregnancy for patients with high unmet need
The Innovation Passport is a designation for innovative medicines. It is the entry point to the Innovative Licensing and Access Pathway (ILAP), which aims to accelerate the time to market for innovative medicines that address the needs of patients with life-threatening diseases2
Preeclampsia is a life-threatening high blood pressure disorder of pregnancy that globally kills 500,000 infants every year. A disease which currently has no therapeutic options and is a major public health burden affecting almost 10 per cent of all pregnancies. Survivors of preeclampsia have a reduced life expectancy and an increased likelihood of developing future chronic diseases3
MirZyme is excited to explore the opportunities through this fast-track regulatory pathway to accelerate patient’s potential access to MZe786
MirZyme is committed to making preeclampsia history and ensuring their medicines have a global reach to all patients who may require them
Birmingham, UK, 8 November 2022 — MirZyme Therapeutics, a leading femtech biotech company developing targeted drugs, is pleased to announce their first investigational oral therapy, MZe786, has been awarded an Innovation Passport for the treatment of preeclampsia, a joint award from the Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC).1
The Innovative Licensing and Access Pathway (ILAP) was launched in January 2021 to expedite the development and access to novel medicines for patients in the UK following Brexit and is composed of partners within the ILAP Steering Group; the ll Wales Therapeutics and Toxicology (AWTTC), MHRA, National Institute of Clinical Excellence (NICE) and Scottish Medicines Consortium (SMC). The ILAP is a government pathway open to both commercial and non-commercial developers of medicines. It comprises an Innovation Passport designation and a Target Development Profile (TDP), providing applicants with access to a toolkit of regulatory and practical support at all stages of the design, development and approvals process.
This Innovation Passport was awarded due to MZe786 successfully fulfilling the following criteria:
1) Treatment of a life-threatening condition or a significant public health need
2) The programme being an innovative medicine: advanced therapy medicinal product (ATMP) and new biological entity
3) A medicine for a special population, in this case - pregnant women
4) It aligns with the objectives for UK Public Health & Social Care (DHSC)
5) A medicine with a potential to offer benefits to patients
“Receiving the Innovation Passport designation is a milestone in MirZyme’s regulatory strategy and in the development of MZe786. It offers the potential to accelerate the development of this novel small molecule as the first integrated treatment option for those patients who may develop preeclampsia. I am delighted MZe786 has received this recognition. This will facilitate frequent valuable discussions with the review staff at the MHRA and its partner agencies on the product’s development and reimbursement” said Dr Malcolm Barratt-Johnson, MD, a Board Member of MirZyme Therapeutics.
A Maternal-Fetal Medicine specialist, Swati Agrawal MD, MRCOG, at McMaster University Medical Centre in Canada, where the outputs from the Innovation Passport process will also apply, said, “As a high-risk obstetrician and a woman wanting to have a family, a solution to preeclampsia is badly needed. I believe that MZe786 is the drug that we had been waiting for. If this drug performs as well in humans as it did in animal models, then it has the potential to save many lives”.
Breakthrough drug and next pathway steps
The innovation Passport is the first step towards implementing a new treatment within the ILAP process. The next step will be development of a product-specific Target Development Profile (TDP) for the new drug, which will be created by MirZyme working alongside the MHRA and its partners. As a living document, the TDP will create a roadmap with the objective of delivering early patient access to this treatment.
In vivo, oral administration of MZe786 in mice has shown that MZe786 is effective in improving maternal and fetal outcomes. MZe786 reduces blood pressure and prevents major organ damage in the mother,improves fetal weight and decreases fetal mortality. MZe786 causes the upregulation of antioxidant defence genes and suppresses the production of a small molecule, soluble Flt-1. MZe786 is the first of several therapeutics under development at MirZyme.
This experiential treatment will be offered to women who are identified in the early stages of pregnancy at high risk of developing preeclampsia by MirZyme’s game-changing “rule-in” diagnostic tool that is able to accurately detect preeclampsia in a pregnant woman prior to being symptomatic of the condition.
MirZyme Therapeutics is an innovative biopharmaceutical company (www.Mirzyme.com) based in Birmingham, U.K. that has a digital solution to predict and novel therapeutics to potentially prevent preeclampsia, a life-threatening disease of pregnancy.
There are currently no accurate “rule-in” diagnostics or approved therapeutics available for the prevention and treatment of preeclampsia. MirZyme’s mission is to make preeclampsia history with its patented new technology, and to save the lives of both mother and baby; one test, one pill, save two lives®.
It is focused on a stratified approach to identify patients who will develop preeclampsia and offer pathogenesis-targeted therapeutics to prevent it. MirZyme’s value proposition is to save lives, reduce healthcare costs and promote healthy longevity by stopping irreversible molecular damage before it starts in utero.
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Media and Communication Contact
MZE786 - Approval Letter Innovative Licensing and Access Pathway.
Innovative Licensing and Access Pathway. Guidance. Available at: https://www.gov.uk/guidance/innovative-licensing-and-access-pathway
Asif Ahmed & Wenda Ramma. Unravelling the theories of preeclampsia: are the protective pathways the new paradigm? Br J Pharmacol. 172:1574-86, 2015. doi: 10.1111/bph.12977.
Read The Guardian Article 'Pill to prevent pre-eclampsia gets UK fast track for development'