Cascade is a biotech focusing on innovative drugs development targeting nuclear receptors and G protein coupled receptors (GPCRs) for metabolic and inflammatory diseases. We are currently developing CS0159 (Linafexor) for the treatment of nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC).
The first and most preferable route for patients to access our investigational products prior to approval is participation in our clinical trials, which are managed by a team of medical experts and are designed to determine whether the investigational products are safe and effective. You can learn more about our ongoing clinical trials by visiting Clinicaltrials.gov web site.
There may be situations where a patient with a serious or life-threatening condition who has exhausted treatment options will not qualify for clinical trials and may seek access to an investigational medicine outside of a clinical trial setting. This process is known as expanded access, sometimes called compassionate use. Per FDA, expanded access may be considered when:
• Patient has a serious disease or condition, or whose life is immediately threatened by their 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.
• Potential patient benefit justifies the potential risks of treatment.
• Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
Currently, Cascade is not able to provide expanded access or right to try basis options to its investigational drugs. In the future, Cascade may reassess expanded access as the advance in clinical trials and more data available to support the safety and effectiveness.
If you have any question about Cascade’s expanded access policy, please contact Cascade at expandedaccess@cascadepharm.com.
Consistent with the 21st Century Cures Act, Cascade may revise this expanded access policy at any time. Additionally, the posting of this policy by Cascade shall not serve as a guarantee of access to any specific investigational drug by any individual patient.
