Compassionate access to treatment

F2G is aware that there are limited treatment options available for some patients with rare and difficult-to-treat mould infections. While we recognize the medical need, we must also work within the confines of a drug development system and the limitations that imposes. Our lead compound, olorofim, is currently in an early stage of clinical development and as such its safety and effectiveness are still being evaluated.

We are working with the regulatory authorities around the world to develop a clinical program that will provide us with the necessary data to seek marketing approval of olorofim in the pool of patients who are most likely to benefit. Our goal is to conduct this clinical program rapidly yet without sacrificing the scientific rigor that a global marketing authorisation requires.

In addition, we have limited resources and are only able to produce sufficient olorofim for use in clinical studies. Providing olorofim for a pre-licence access program would unfortunately restrict our ability to conduct the olorofim clinical program in a timely fashion.

As a consequence of these constraints, the only path to olorofim is via enrolment at one of our existing study sites. If possible and subject to logistical limits, we will work to find a way to transfer and enrol eligible patients at one of these sites. We are not otherwise providing olorofim on “compassionate use” or “early access” grounds at this time.

Should you require more information on our clinical program

Please look at our study page on
https://clinicaltrials.gov/ct2/show/NCT03583164?term=F2G&cond=mould+infection&rank=1

Alternatively, please contact F2G medical information on medinfo@f2g.com