Comanche Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for CBP-4888, an siRNA Investigational Therapy for the Treatment of Preeclampsia

CONCORD, Mass., March 30, 2023 /PRNewswire/ -- Comanche Biopharma Corp., a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for Comanche's novel, siRNA therapy to treat preeclampsia. Preeclampsia is a prevalent hypertensive disorder of pregnancy for which there is no existing therapy that can modify disease progression.

"The FDA's clearance of CBP-4888 allows us to take another major step toward developing a treatment for preeclampsia," said Scott Johnson, M.D., Co-Founder and CEO of Comanche Biopharma. "We will now move expeditiously into a first-in-human clinical trial to evaluate this potential therapy."

CBP-4888 is a subcutaneously delivered siRNA therapeutic that decreases the production of soluble fms-like tyrosine kinase-1 (sFLT1) in the placenta. A primary cause of preeclampsia is an excess production of the protein sFLT1 by the placenta that enters the mother's bloodstream. CBP-4888 can potentially ameliorate the symptoms of preeclampsia, including high blood pressure and damage to organs such as the kidneys and liver, and may enable the safe prolongation of pregnancy.

"New scientific discoveries around siRNA and sFLT1 have created a breakthrough to provide clinicians a potential treatment option for patients suffering with preeclampsia," said Allison August, M.D., Chief Medical Officer of Comanche. "Against the backdrop of a worldwide failure to make progress on the leading causes of maternal mortality, these new developments offer possible hope to the millions affected by preeclampsia every year."

Preeclampsia complicates 10 million pregnancies globally, leading to approximately 46,000 maternal and 500,000 fetal and newborn deaths every year. Currently, the only proven course of action is to deliver the baby and remove the placenta.

Comanche is committed to lowering the risks of pregnancy and prematurity worldwide by safely sustaining natural pregnancy.

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About CBP-4888

CBP-4888 is a fixed-dose combination of two chemically-synthesized, lipid-conjugated small interfering ribonucleic acid (siRNAs) duplex oligonucleotides (siRNA-2283 and siRNA-2519) targeting two soluble fms-like tyrosine kinase–1 (sFLT1) mRNA isoforms.  

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 46,000 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, those living in low- and middle-income countries, and those residing in rural areas.

The signs and symptoms of preeclampsia can vary and include high blood pressure, acute kidney injury, swelling in the hands and face, severe headaches, vision changes, and abdominal pain. Treatment may include close monitoring of blood pressure and urine protein levels, bed rest, and medication to lower blood pressure. Currently, delivery of the baby is the only definitive cure for preeclampsia.

About Comanche Biopharma Corp.

Comanche Biopharma is a maternal and fetal medicine biopharmaceutical company working to lower the risks of pregnancy and premature births worldwide. We are currently developing the world's first treatment for preeclampsia, which affects more than 10 million women every year.

Comanche's mission is to eradicate preeclampsia globally. Comanche Biopharma´s founders have had successful careers discovering new medicines, building and selling companies, and taking on some of the hardest challenges in medicine. Ours is a new company with leaders who already have an established reputation for excellence, including scientific advisors like Nobel Laureate Craig Mello who discovered RNA interference and Ananth Karumanchi who first identified the protein at the core of our work, and is at the core of the first diagnostic test currently used in the standard of care for the management of patients with preeclampsia in the European Union and United Kingdom.

We are harnessing the power of these two recent scientific breakthroughs to finally bring an effective treatment for preeclampsia to the global marketplace. Together, our team is taking on one of the hardest challenges of maternal and fetal health, including breaking the embargo on offering pregnant women the choice to participate in clinical research.

We are committed to the ethical representation of people of all colors and economic status globally in our clinical development programs. We prioritize ensuring access to our solutions by those who need them most.

SOURCE Comanche Biopharma