PureTech Expanded Access Policy

PureTech is committed to developing safe and effective therapies dedicated to changing the lives of patients with devastating diseases. Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for those patients in need.

Expanded access refers to treatment with an investigational medical therapy outside a clinical trial for a patient with a serious or immediately life-threatening illness when there are no comparable or satisfactory alternative treatments available. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected. PureTech understands the need for expanded access programs, and we recognize the importance of having an appropriate policy.

PureTech will utilize the following criteria when considering making one of our investigational medicines available to individuals under an expanded access program:

  • The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or enrolling clinical trials)
  • There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information
  • Ability to provide a product in a fair and equitable manner, so that there is adequate manufacturing capacity for ongoing programs
  • Expanded access is permitted under applicable law and regulation
  • Whether granting expanded access would potentially compromise the scientific validity of broader development programs or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients

At this time, participation in one of our clinical trials is the only way to access our investigational therapies; however, PureTech cannot guarantee that an investigational drug will be available to any particular patient. Any expanded access requests will be referred to study investigators to determine whether a patient is eligible for one of our ongoing clinical trials. If a patient does not qualify for one of our ongoing clinical trials, PureTech will direct such patients, caregivers, and/or their treating physician to patient organizations and/or academic centers who may be able to identify other appropriate clinical trials or approved treatment options.

. This policy is subject to change as PureTech may revise this policy at any time and may establish different expanded access policies for each investigational drug under development. It is also important to understand that the expanded access of an investigational drug may be discontinued at any time at the discretion of the treating physician, the patient or their caregiver, the local regulatory agency, such as the FDA, or PureTech. At this time, PureTech does not have any expanded access programs open.

Patients should speak with their physician to determine if a PureTech investigational medical therapy is right for them. To inquire about potential expanded access, a licensed healthcare professional should contact PureTech at This email address is being protected from spambots. You need JavaScript enabled to view it.. PureTech will acknowledge receipt of requests or inquiries sent to this email within 5 business days.

Information about PureTech’s clinical trials may be found at www.clinicaltrials.gov.