Expanded Access Policy:

 

LISCure Biosciences is a clinical-stage pharmaceutical company focusing on the development of microbiome-based novel drugs against diseases with high unmet medical needs.

There may be patients facing serious or life-threatening diseases who may not qualify for an ongoing clinical trial, but who may benefit from an investigational drug. For these patients, the patient’s physician may choose to request access to an investigational drug outside of a clinical trial through an expanded access program. The following criteria and applicable regulations should be taken into account:

·   Patient has a serious or immediately life-threatening disease or condition.

·   There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.

·    Patient enrollment in a clinical trial is not possible.

·    There are sufficient clinical data available from its existing clinical trials to anticipate that the potential benefits justify the potential risks to the patient

·    Providing the investigational drug will not interfere with clinical trials that could support a investigational product’s development or marketing approval for the  treatment indication.

 

At this time, LISCure Biosciences does not open expanded access program as we are in early stage of development. We believe that participating in our clinical trials is the most appropriate way to access our investigational drugs because the clinical trials are the most effective way of generating safety and efficacy data for review and decision making by regulatory authorities. When more clinical data is available, LISCure Biosciences continues to evaluate it and assess the criteria for expanded access program and will update this policy from time to time.

 

If you are a patient or healthcare provider interested in learning more about our investigational drugs and participating in our clinical trials, please contact us at: clinical@liscure.bio . LISCure will acknowledge receipt of your inquiries within 5 business days of receipt.