- ILAP aims to accelerate time to market, facilitating faster patient access to clinically important and promising medicines being developed to address significant health needs
- Preeclampsia is a serious obstetric complication that threatens the life of both mother and baby, often resulting in preterm delivery
- Globally, preeclampsia is a leading cause of maternal and infant morbidity and mortality and can result in lifelong consequences
- A novel investigational drug candidate, CBP-4888 leverages the precise targeting ability of siRNAs to downregulate sFlt1 in the placenta, a key pathogenic mediator of preeclampsia
"We are grateful to the Innovative Licensing and Access Pathway (ILAP) Steering Committee for awarding the Innovation Passport designation to CBP-4888. We look forward to collaborating with U.K. regulators to help accelerate the development of this important therapeutic for pregnant patients,” said Allison August, M.D., Chief Medical Officer at Comanche Biopharma. "For hundreds of years, the treatment of preeclampsia has remained unchanged. The awarding of this designation amplifies the significant unmet need that preeclampsia presents for pregnant women and their babies in the U.K. and globally and signals the innovation our siRNA therapeutic candidate could potentially deliver.”
Preeclampsia is a serious obstetric complication that threatens the life of both mother and baby, often resulting in preterm delivery. Globally, preeclampsia is a leading cause of maternal and infant morbidity and mortality and can result in lifelong consequences. Overexpression of the protein sFlt1 is regarded as a key pathogenic mediator of preeclampsia. When produced in excess by the placenta, sFlt1 is toxic, severely damaging the mother's blood vessels and impairing the growth of new ones. This overproduction of sFlt1 and subsequent vascular damage result in the common maternal signs and symptoms of preeclampsia and in fetal growth restriction.
CBP-4888 is designed to achieve sufficient uptake by the placenta to selectively downregulate the disease-causing overexpression of the sFlt-1 protein in patients with sFlt-1-mediated preterm preeclampsia. CBP-4888 is being investigated for the potential to ameliorate the acute, potentially life-threatening maternal symptoms of preterm preeclampsia. This, in turn, may enable the safe prolongation of pregnancy and continued fetal maturation, thereby minimizing the short- and long-term mortality and morbidity associated with prematurity.
About ILAP
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) launched ILAP at the start of 2021 in order to accelerate the development and access to promising medicines in the early stages of development. The pathway features enhanced input and interactions with MHRA and its partner agencies, including the All Wales Therapeutics and Toxicology Centre (AWTTC), the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). Other benefits of ILAP include access to a range of development tools, such as the potential for a 150-day accelerated Marketing Authorization Application (MAA) assessment, rolling review and continuous benefit risk assessment. More information about ILAP can be found here.
About Preeclampsia
Preeclampsia is a prevalent and serious pregnancy complication that affects up to 8% of pregnancies worldwide. It can lead to a range of complications for both the mother and the baby, including multi-organ damage, seizures and premature birth. Globally, there are an estimated 76,000 maternal deaths and 500,000 fetal and newborn deaths annually due to this pregnancy complication. While preeclampsia can develop in any pregnancy, it disproportionately affects black individuals and those living in low resource settings. The signs and symptoms of preeclampsia can vary and include high blood pressure, acute kidney injury, swelling of the hands and face, severe headaches, vision changes and abdominal pain. Currently, premature delivery of the baby is the only available option for stopping the progression of preeclampsia.
About Comanche Biopharma Corp.
Comanche Biopharma is a clinical stage biopharmaceutical company working to make every pregnancy around the world safer through innovative and equitable solutions. We are currently developing CBP-4888, an innovative siRNA therapeutic candidate that, if approved, would be the world's first treatment for preeclampsia, an obstetric complication globally responsible for a significant burden of maternal and infant morbidity and mortality. At Comanche, we are committed to the ethical representation of people of all colors and economic status globally in our clinical development programs. We plan to prioritize ensuring access to our solutions for those who need them most. Visit us at comanchebiopharma.com.
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