Access to Olorofim, including Expanded Access (Compassionate Use)

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. Consequently, olorofim has not yet reached the stage where it can be considered ready for Expanded Access or Compassionate Use.

We are working with the 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 currently the only 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 enroll 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 contact F2G medical information on medinfo@f2g.com. When you write, please limit your initial email to your contact details and a very brief outline of the patient’s circumstances. 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.