Comanche Biopharma Announces European Medicines Agency (EMA) Has Granted Orphan Drug Designation for CBP-4888 in sFlt1-mediated Preterm Preeclampsia

• EMA orphan drug designation is awarded to drugs intended to treat rare diseases that are life-threatening or chronically debilitating
• Preeclampsia, a serious obstetric complication, is a leading cause of near-term morbidity and mortality for mothers and their babies, and can lead to long-term consequences for both
• An investigational drug candidate, CBP-4888 leverages the precise targeting ability of siRNAs to downregulate sFlt1, a key pathogenic mediator of preeclampsia, in the placenta
• CBP-4888 represents the first potential molecularly targeted therapeutic for an obstetrical indication

/EIN News/ -- CONCORD, Mass., April 08, 2025 (GLOBE NEWSWIRE) -- Comanche Biopharma Corp. today announced that the European Medicines Agency (EMA) has granted orphan drug designation for CBP-4888 for the treatment of sFlt1-mediated preterm preeclampsia. A serious obstetric complication, preeclampsia is estimated to impact approximately four in 10,000 pregnancies in the European Union each year. A novel siRNA drug candidate, CBP-4888 is designed to downregulate overexpression of the protein sFlt1, a known pathogenic mediator of preeclampsia, in the placenta. Currently an investigational drug candidate, CBP-4888 has the potential to be the first precision medicine for an obstetrical indication.

“We are grateful to the EMA for granting orphan designation to CBP-4888 and recognizing preeclampsia as a life-threatening, significant unmet medical need,” said Allison August, M.D., Chief Medical Officer at Comanche Biopharma. “Beyond the acute morbidity and mortality risk that preeclampsia presents for mothers and their babies, it is also associated with serious, lifelong health complications. By targeting a root cause of preeclampsia with a precision medicine, our goal is to provide a therapeutic solution that can prevent the far-reaching, short- and long-term impact of this condition for mothers, babies, families and society at large.”

The EMA grants orphan drug designation to drugs and biologics intended for the treatment, prevention or diagnosis of a life-threatening or chronically debilitating disease that affects fewer than five in 10,000 people in the European Union, and with either no currently approved method of diagnosis, prevention or treatment or with significant benefit to those affected by the disease. Sponsors who obtain orphan drug designation benefit from protocol assistance, market exclusivity and regulatory fee reductions.

About sFlt1 and CBP-4888
Overexpression of the protein sFlt1 is believed to be 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 near-term morbidity and mortality for mothers and their babies, and the potential long-term consequences for both.

In addition to receiving Orphan Drug Designation by the EMA, CBP-4888 has also received Fast Track Designation by the U.S. Food and Drug Administration, and Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group.

About Preeclampsia
Preeclampsia is a serious pregnancy complication that affects up to 8% of pregnancies worldwide. It can lead to a range of acute, near-term complications for both mothers and their babies, including multi-organ damage, potential progression to eclampsia (onset of seizures) and premature births. Preeclampsia can also result in lifelong consequences, such as a higher risk of heart disease, chronic hypertension, cardiovascular disease and stroke for women, and learning disorders, cerebral palsy, epilepsy, blindness and deafness for infants born prematurely.

Globally, there are an estimated 76,000 maternal deaths and 500,000 fetal and newborn deaths annually due to this complication of pregnancy. 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 by delivering innovative solutions and ensuring they are accessible to patients in need. We are currently developing CBP-4888, an innovative siRNA therapeutic candidate that, if approved, would be the world’s first treatment to target an underlying cause of preeclampsia, an obstetric complication globally responsible for a significant burden of maternal and infant morbidity and mortality, which can also lead to long-term consequences for both mothers and their babies. At Comanche, we are committed to the ethical representation of people of all colors and economic status globally in our clinical development programs. Visit us at comanchebiopharma.com.

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