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Expanded Access Policy

Many team members at Comanche Biopharma are survivors of preeclampsia and understand firsthand just how frightening and difficult this disease can be.

After you or a loved one is diagnosed with preeclampsia, the first step is often to find out everything you can about the disease and its management. The available information can be confusing and the choices agonizing. Please visit our resources page for links to organizations that can best support you.

Unfortunately, there currently exists no approved therapeutic treatment that can modify the progression of preeclampsia. Our lead investigational product, CBP-4888, is progressing through human clinical trials to determine whether it may be safe and effective and offers an acceptable balance of risks and benefits in patients with sFlt1-mediated preterm preeclampsia.

Sometimes called “compassionate use”, expanded access is a potential regulatory and legal pathway for a patient with a serious or immediately life-threatening disease to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

At this time, we do not offer an expanded access program and are not accepting expanded access requests for our investigational product CBP-4888. We are dedicated to generating additional data about CBP-4888 and will continually reassess to determine if and when we might be able to support expanded access requests by your treating physician.

Safety is our top priority, especially for a patient population as complex as pregnancy. The development process for a new medicine takes many years, many steps, and many patients. It is an iterative process that requires producing evidence of safety, tolerability, dosage, efficacy, quality, and outcomes (in this case for both mom and baby) to determine its potential risks weighed against its potential benefits. Not all investigational drugs show evidence of effectiveness or safety, and the earlier in the development process, the less we know.

Whatever your situation, please know that we care deeply about you as a person and a patient.

Additional information about expanded access is available at https://www.fda.gov/news-events/public-health-focus/expanded-access

For questions regarding our current expanded access policy, please contact Allison August, M.D., Comanche Biopharma at allison@comanchebiopharma.com

Information regarding Comanche Biopharma’s clinical trials, as well as clinical trials and expanded access programs for other potential therapies, can be found on www.clinicaltrials.gov

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50 Beharrell St, Unit B
Concord, MA 01742

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Comanche is a biopharmaceutical company developing a novel siRNA therapy for the treatment of preeclampsia. Our purpose is to lower the risks of pregnancy and prematurity worldwide by safely sustaining  pregnancy. We envision a world where all pregnant women have access to safe and effective therapies that are evidence-based, cost-effective and sustainable.

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FIGO XXIV

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