Expanded Access Policy

Expanded Access, also known as “Compassionate Use” is a program that allows the individual patient use of an investigational medicinal product for an immediately life-threatening and serious disease or condition when enrollment in a clinical trial is not possible and no alternative therapy is available. This program only applies to medicines that have not yet been approved by the Food and Drug Administration (FDA). In considering a patient for Expanded Access, a doctor must decide whether the potential benefit outweighs the potential risk of receiving an investigational or unapproved medicine, based on the individual patient’s medical history. Because these drugs have yet to be approved, the full potential of their risks and benefits are not known.

The Pliant PLN-74809 program is still in early stage clinical development. As such, the benefit-risk assessments of PLN-74809 use are still being defined through ongoing clinical research and development. After careful consideration, Pliant Therapeutics does not feel there is enough information needed to assess whether the benefit outweighs the potential risk at this time. As a result, Pliant is not offering an Expanded Access to our investigational drug. We may consider offering this program as more information is revealed through progression of our investigational medicines through the various stages of clinical research and development.

For any further enquiries, Pliant can be reached at IR@PliantRx.com.