Concord, Mass., August 23, 2023 — Comanche Biopharma Corp. today announced that they have received Fast Track designation from the U.S. Food and Drug Administration (FDA)for the investigation of CBP-4888 for the treatment of sFlt1-mediated pre-term preeclampsia. CBP-4888 is a subcutaneously delivered siRNA therapeutic that is currently in a Phase 1 clinical trial. The FDA’s Fast Track program is designed to facilitate the development, and expedite the review of, novel potential therapies that are designed to treat serious conditions and address an unmet medical need.
“We are grateful to the FDA for recognizing the potential of our novel siRNA investigational drug, CBP-4888, to help address the escalating maternal health crisis,” said Scott Johnson, M.D., Co-Founder and CEO of Comanche Biopharma. “This designation offers increased collaboration with the FDA to help ensure that CBP-4888 reaches patients expeditiously while maintaining the highest standards of safety and quality.”
Preeclampsia afflicts more than 10 million women every year around the world with devastating short- and long-term consequences to both mother and baby. Currently no existing therapy can modify the disease progression of preeclampsia. “Complications from preeclampsia lead to approximately 80,000 maternal and 500,000 fetal and newborn deaths globally every year,” said Allison August, M.D., Chief Medical Officer of Comanche Biopharma. “Currently, the only cure for preeclampsia is premature delivery. Today’s FDA Fast Track designation brings us one step closer to our shared goal of advancing a safe and effective treatment option for patients with preeclampsia.”
Comanche is committed to lowering the risks of pregnancy and prematurity worldwide by safely sustaining natural pregnancy.
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About FDA Fast Track
Fast track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. For a more information on the Fast Track Drug Development Program’s requirements and benefits, please visit the FDA’s official page.
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.
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 80,000 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.