Expanded Access Policy

Centessa Pharmaceuticals’ mission is to bring impactful new medicines to patients. To accomplish this mission, Centessa conducts clinical trials to evaluate the safety and efficacy and risk / benefit profile of investigational medical products in development. Clinical trials provide a pathway to regulatory approval, which in turn enables access to treatment for most patients. As a result, Centessa focuses its efforts on designing and conducting clinical trials that, if successful, will ultimately lead to regulatory approval and broad patient access.

Centessa recognizes circumstances may arise in which a patient has a serious or life-threatening disease or condition, has exhausted all available therapy options, and is ineligible or unable to participate in a clinical trial. In such a situation, subject to specific criteria and compliance with any applicable local laws or regulations, a treating physician may submit, on behalf of a patient, an expanded access request (otherwise known as “early access” or “compassionate use”) to Centessa for an investigational medical product that is in active development by one of Centessa’s subsidiary companies and is not approved for marketing by a regulatory authority.

Centessa will evaluate such requests for expanded access, considering first and foremost patient safety and the associated risk / benefit of the investigational medical product. Centessa must also consider how best to provide fair and equitable access, while ensuring the expanded access program does not compromise the scientific validity of the broader clinical development for the investigational medical product or interfere or delay current clinical trials or potential regulatory review and approval for the benefit of the greatest number of patients.

To submit a request, please email ExpandedAccess@centessa.com. Centessa will evaluate each submitted request.

Centessa believes this policy on expanded access is consistent with the Right to Try Act under the laws of the United States. Please also note that in some countries such expanded access may not be possible due to the regulatory restrictions.

For details on our current clinical trials, please visit www.clinicaltrials.gov (US), www.clinicaltrialsregister.eu (EU), or registries in other jurisdictions.

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SerpinPC

Overview
SerpinPC is a subcutaneously administered novel inhibitor of APC being developed as a potential treatment for hemophilia, regardless of severity or inhibitor status, and may also prevent bleeding associated with other bleeding disorders. Centessa is advancing the registrational program for SerpinPC in hemophilia B, which includes a set of clinical studies with multiple components. PRESent-5, initiated in late 2022, is an observational feeder study to collect prospective observational data for minimum defined periods before switching to dosing subjects in the interventional studies. The interventional studies include PRESent-2 (moderately severe to severe hemophilia B without inhibitors, and severe hemophilia A with and without inhibitors) and PRESent-3 (hemophilia B with inhibitors). Additional information on the trials can be accessed at www.clinicaltrials.gov  (NCT05605678NCT05789524NCT05789537). SerpinPC is an investigational agent that has not been approved by the FDA or any other regulatory authority.

Reason to Believe in Target
Human Genetics Support

Epidemiology
~20,000 persons with hemophilia in the United States
450,000 estimated global prevalence
Disease

Hemophilia B