Expanded Access Policy for Investigational Medicines

 An investigational product is a drug product that has not been approved by FDA.  Expanded access refers to the use of an investigational product outside of a clinical trial in the setting of a serious and life-threatening illness where there are no other treatment options, potential patient benefit justifies the potential risks of treatment, and providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

Spero’s Expanded Access policy:

Spero Therapeutics is committed to advancing novel treatment approaches for bacterial infections.  Further, Spero is dedicated to delivering differentiated medicines to help patients suffering from serious rare orphan diseases and life-threatening infections.

Spero’s position is that enrollment in a Spero-sponsored clinical trial is the preferred route of access to our investigational drug products. Information about ongoing clinical trials is posted publicly at www.ClinicalTrials.gov.

None of Spero’s investigational drug products are available for expanded access at this time.

For additional information please contact: expandedaccess@sperotherapeutics.com

This policy is subject to change at Spero’s sole discretion and updates to the policy will be posted on this website.

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