access

Leap Therapeutics

Post-Trial Access – Continued treatment for patients successfully completing one of our clinical studies
Early Access – The provision of access to a Leap Therapeutics IMP for patients suffering from a disease that is not possible to be treated with currently available medicines, or patients are not able to participate in one of our clinical studies.

There is a need for ongoing treatment with an IMP, we recognize that this must be through normal health services once it is available for prescription. As such we will only conduct clinical studies and provide early access outside of studies, in those countries where Leap Therapeutics intends to make the medicine available through normal prescription channels after its approval.
There are sufficient clinical data available with respect to both the IMP, molecular science, and the disease condition for which the request is being sought to anticipate that any potential benefits from treatment are likely to outweigh any associated risks to the patient
While addressing this patient need, Leap Therapeutics will ensure that if we agree to provide early access to the IMP, that there is sufficient medicine available to ensure the supply will not be compromised for those patients receiving it through the early access program, or for those patients in our clinical studies. This is because we want to ensure that when providing early access, it does not prevent us completing clinical studies and regulatory approval that would lead to wider access through normal routes of prescription. Any early access programs we provide will be in line with the laws and regulations of the country involved.