SUPPORTING PATIENTS WITH PJI

Peptilogics is an early clinical stage company dedicated to developing innovative peptide therapeutics. In general, new therapeutics must be reviewed and approved by a regulatory authority, such as the U.S. Food and Drug Administration (FDA), before they become commercially available to patients. Investigational therapies that have not yet been approved by FDA may or may not be effective as a treatment, and might cause unexpected serious side effects.

We encourage patients to participate in clinical trials, which offer the best opportunity for patients to access an investigational product before regulatory approval. Clinical trials are designed to evaluate whether an investigational therapy is safe and effective for patients. Data generated by clinical trials are then evaluated by regulatory authorities to determine whether the investigational product can be approved for commercialization.

In rare cases, where a patient does not meet the requirements for participation in a clinical study, the FDA may grant permission, upon request by a treating physician, for a pharmaceutical manufacturer to provide an unapproved therapy to the treating physician for a qualifying patient through a process called expanded access, also known as compassionate use. Expanded access programs are not available by every pharmaceutical manufacturer or for every investigational therapy. At this time, participation in clinical trials is the only way for patients to gain access to investigational therapies under development by Peptilogics.

Peptilogics encourages patients to speak with their physicians about possible clinical trial participation. Information about our investigational therapies and ongoing clinical trials can be found on clinicaltrials.gov. We reserve the right to review and amend this policy in the future, including based on information from ongoing and future clinical development.

For any questions, please contact patients@peptilogics.com. We will acknowledge receipt and respond to inquiries within seven (7) days. As more information and clinical data becomes available, Peptilogics will re-evaluate our policy.