F2G is aware that when there are limited treatment options available for life-threatening medical conditions, patients or their doctors may request treatment with an investigational drug on a Compassionate Use or an Expanded Access basis. While we recognise this applies to patients with rare and difficult-to-treat mould infections, our lead compound, olorofim, is currently at an early stage of clinical development and its safety and effectiveness are still being carefully evaluated in clinical trials.
We are working with regulatory authorities around the world to implement a clinical program that will provide us with the necessary data to seek approval of olorofim for use in patients who are likely to benefit. Our goal is to conduct this clinical program rapidly yet without sacrificing scientific rigor.
F2G are currently conducting a study of olorofim as treatment for invasive fungal infections (NCT03583164, go here for details on clinicaltrials.gov). Enrolment in this study at one of our trial sites is considered the appropriate way for patients to be treated with olorofim. To be enrolled, patients must meet the eligibility criteria described briefly on the clinicaltrials.gov website and in more detail in the study protocol. If possible and subject to logistical limits, we will work to find a way to transfer and enrol eligible patients at one of the study sites.
If you are a licensed physician and believe you might have a patient who would be suitable for this trial, please review the enrolment criteria and then contact F2G medical information on email@example.com. When you write, please limit your initial email to your contact details and a very brief outline of the patient’s clinical case and why they may be eligible. Please do NOT send any personal identifiers or detailed information regarding the patient. We will advise on next steps. We endeavour to respond to all enquiries within 2 working days.
If you are a patient and believe you might be appropriate for this trial, please ask your physician to contact us as outlined above
In exceptional circumstances, where enrolment in a clinical trial is not possible due to location of the patient and/or inability to transfer the patient to a study site, F2G may consider a patient as eligible for compassionate access to olorofim. In such circumstances, the factors F2G will take into consideration include (amongst others) the age of the patient, whether they meet all the enrolment criteria for the clinical trial, the ability to obtain all necessary regulatory approvals for use of an unlicensed drug in the patient’s home country and the ability to ship drug in a meaningful timeframe to be able to influence the patient’s outcome. Only if all of these criteria can be satisfied will F2G consider a compassionate access request. Access is not guaranteed. Requests must be submitted in writing by a licensed medical practitioner, to firstname.lastname@example.org providing a clinical summary of the patient’s case. Please do NOT send any patient identifiers with the request.
Requests from patients or family members on behalf of a patient will not be considered. Please speak to your physician about your case.