Expanded Access Policy
Ellodi Pharmaceuticals is committed to developing promising new therapies to address the unmet medical needs of patients suffering from rare and seriously debilitating diseases.
We currently have a late stage investigational medicine in our product pipeline for the treatment of Eosinophilic Esophagitis. Our goal is to provide access to our medicines at the appropriate time and in a manner that is most beneficial to the relevant patient population. We believe enrollment in our ongoing clinical trials are the safest and most effective way of achieving this goal, and we encourage all patients and physicians to visit clinicaltrials.gov to find out about enrolling.
However, we recognize that some patients who wish to access our medicines will not be eligible for our clinical trials and may have no other viable treatment options available to them. In these situations, Ellodi Pharmaceuticals will consider providing access to our investigational medicine, outside of the clinical trial setting, when certain conditions are met. These conditions are as follows:
- The patient to be treated has a serious or immediately life-threatening illness and there is no satisfactory alternative therapy.
- The patient is not eligible for, or cannot access, any ongoing clinical trials.
- The potential benefit of the investigational medicine to the patient outweighs the potential risk. This should be evaluated by your physician and discussed in detail with the patient.
- There is an adequate supply of the investigational medicine, meaning the Sponsor has surplus investigational drug over and above what is required for the ongoing clinical trials.
- Providing the investigational drug will not interfere with clinical trials that could support a medical product’s development or marketing approval.
Requests for our investigational medicines must come from a patient’s treating physician. Ellodi and/or it’s designee Clinical Research Organization (CRO) will assist with regulatory submissions required for participation when the patient is approved for inclusion in the program. The physician must comply with various regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting.
Ellodi Pharmaceuticals is committed to providing a fair and equitable evaluation of all the requests we receive. We will review requests on a case by case basis, and the fact that our treatment is made available to one patient, does not guarantee it will be made available to future patients. We continually evaluate the benefit-risk profile of our investigational drugs, and, based on evolving clinical data, we may require additional information from a treating physician in order to fully evaluate a request. We cannot guarantee that all requests for access will be granted, even when eligibility criteria are met.
Physicians seeking access to a Ellodi Pharmaceuticals investigational medicine should submit their requests to EAP@ellodipharma.com. We regularly monitor this mailbox, and we will acknowledge each submitted request within 7 business days after receipt. You can find further contact details on the Contact Us page of our website. Information on publicly and privately supported clinical trials on a wide range of diseases and conditions is available at ClinicalTrials.gov, a Web-based resource maintained by the National Library of Medicine for patients, their families, health care professionals, researchers, and the public.