ACCESS TO MEDICINES PRIOR TO REGULATORY APPROVAL

Rapport Therapeutics is committed to developing innovative, safe and effective therapeutics to improve the lives of patients with neurological or psychiatric disorders, and we recognize the value of collaborating with patients, families, advocacy organizations, physicians and other healthcare professionals, researchers and regulatory authorities to accomplish this goal. Well-designed clinical trials are the best way to understand a drug’s effectiveness and safety and are necessary to obtain approval for a medicine.

We understand that patients, families and physicians may be interested in accessing Rapport’s investigational drugs prior to regulatory approval through an expanded access program (sometimes referred to as “compassionate use program”). Expanded access programs allow patients with serious or immediately life-threatening diseases, who have exhausted all other treatment options, to access an investigational drug outside of a clinical trial, and prior to regulatory approval.

Rapport does not currently have an expanded access program that makes our investigational drugs available to patients other than by participating in one of our clinical trials. Clinical trials are controlled studies in humans designed to establish whether an investigational drug is safe and effective. Rapport believes clinical trials are the most appropriate way to efficiently collect all data necessary to seek regulatory approvals. At this time, Rapport does not have sufficient information about the potential risks and benefits of our investigational drugs to ensure that patient access outside the regulated clinical trial process does not delay or compromise our clinical trials and, ultimately, broad availability to the entire patient community.

Physicians, patients and caregivers interested in learning more about Rapport’s ongoing clinical trials can find additional information on clinicaltrials.gov.

Rapport may revise this policy at any time. If you have additional questions, please contact us at info@rapportrx.com.