Expanded Access Policy

Expanded Access and Compassionate Use Policy – VectorY Therapeutics

VectorY Therapeutics develops innovative vectorized antibody therapies for neurodegenerative diseases with significant unmet medical need. Our goal is to accelerate access to safe and effective treatments while maintaining the highest standards of ethics and safety.  We believe that carefully designed clinical trials guided by scientific principles and informed by clinician, patient and caregiver insights are the safest pathway to expediting access to our investigational therapies for individuals and families impacted by neurodegenerative diseases. We recognize that there are certain circumstances where an individual or caregiver may seek access to an investigational treatment or medicine outside of a clinical trial. This process is sometimes called “expanded access” or “compassionate use”. For such situations, VectorY Therapeutics has a policy in place. Please, see below more information on our policy.

What is Expanded Access?

Expanded Access (sometimes called “Compassionate Use”) allows qualifying patients with serious or life-threatening conditions to receive an investigational drug outside of a clinical trial when no other satisfactory treatments are available.

Who Might Qualify?

You may be eligible if:

  • You have a serious or life-threatening disease or condition.

  • You are ineligible to join a clinical trial for this drug.

  • No approved treatment options work for you.

  • The potential benefit justifies the potential risks in light of the disease or condition.

  • Providing the drug will not interfere with the initiation, conduct, or completion of clinical trials that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.

Important Things to Know

The drug is still being studied and is not yet approved or proven safe and effective for any use.

  • Your doctor must apply on your behalf and agree to monitor your care.

  • Regulatory and ethics approvals are required before treatment can begin.

  • VectorY Therapeutics must ensure enough supply for ongoing clinical trials, hence availability at the time of a request will depend on our clinical trial supply.

How to Request Access

To request access, ask your doctor to email us at EA@vectorytx.com. We review each request carefully and aim to respond within 10 business days.

Disclaimer

Approval is not guaranteed. Decisions are based on medical need, safety, and regulatory requirements. VectorY reserves the right to update or make changes to this policy at any time. 

Need More Information?

For questions about Expanded Access or our clinical trials, please visit Study Details | NCT07287397 | Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS | ClinicalTrials.gov or contact us at EA@vectorytx.com.