AlgoTherapeutix development resources are focused on conducting clinical studies required by regulatory authorities to fully answer important scientific questions about the potential risks and benefits of our investigational products, and to obtain regulatory approval.

An EAP is intended to allow patient access to an investigational medicine for a serious or immediately life-threatening disease or condition where no comparable or satisfactory alternative therapy exists and when the potential benefit of the medicine justifies the potential risks and those risks are not unreasonable in the context of the disease or condition being treated. Expanded access, sometimes called « compassionate use, » is the use of an investigational medicine (i.e., one that has not been approved by the Food and Drug Administration (FDA)) by a patient who cannot be enrolled in a clinical trial.

At this time, AlgoTherapeutix does not offer Expanded Access Programs (EAPs) at this stage of development since the efficacy of the drug has not been established in randomized double blind placebo controlled trials for its intended use. The latter may be modified once ATX01 efficacy has been established in a Sponsor’s clinical trial.

Scope
This policy applies to provision of access to AlgoTherapeutix investigational product that is not approved for any purpose in the country from which the request is intended to be used. This also includes the time period between regulatory approval of an investigational product and its commercial availability in a country.

Policy Statements
Any use of AlgoTherapeutix investigational product outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including AlgoTherapeutix policies and procedures.

AlgoTherapeutix does not offer Expanded Access Programs (EAPs) for ATX01 at this stage of development since the efficacy of the drug has not been established in randomized double blind placebo controlled trials for it’s intended use. The latter may be modified once ATX01 efficacy has been established in a Sponsor’s clinical trial.