Compassionate Use/Expanded Access Programs

Alector is committed to developing therapies to transform the lives of patients with neurodegenerative diseases. Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for patients.

Expanded access and compassionate use refer to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected. We understand the need and recognize the importance of these programs.

A number of factors consistent with the US Food and Drug Administration (US FDA) and other regulatory agencies’ guidelines should be taken into account when considering expanded access and compassionate use. They include:

• 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
• Whether granting expanded access and compassionate use 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. If an investigational therapy clinical trial has closed, we do not currently offer expanded access or compassionate use for that investigational therapy. Any expanded access or compassionate use 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, Alector 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.

If you have questions, please speak with your physician or contact Alector directly at clinicaltrials@Alector.com. We anticipate acknowledging receipt of requests sent to this email within five business days. In line with the 21st Century Cures Act, Alector may revise this website and programs at any time. This website and the programs will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.