Expanded Access Policy for Investigational Drugs

Purpose

This policy outlines IBT’s approach to Expanded Access (also known as Compassionate Use) for patients who are seeking access to an investigational drug currently in development.

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Background

The 21st Century Cures Act, enacted in 2016, requires manufacturers of investigational drugs for serious diseases or conditions to publicly disclose their policies for handling expanded access requests. Also known as compassionate use, expanded access allows patients to receive investigational treatments outside of clinical trials when no viable alternative therapies are available.

IBT is a pharmaceutical company whose purpose is to develop and commercialize drugs for diseases affecting premature babies. The drug candidate IBP-9414 is a formulated bacterial strain naturally found in human breast milk and is a product for premature infants in the new class of biologics called “Live Biotherapeutic Products”.

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Policy Statement

IBT is dedicated to developing innovative therapies that address serious and life-threatening diseases. IBT recognizes the importance of Expanded Access and understands that patients and healthcare providers may seek early access to promising treatments. Providing access to investigational drugs is a top priority, however IBT is currently unable to offer access outside of a clinical study setting. Consequently, IBP-9414 is not accessible through an Expanded Access Program (EAP).

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Review and Updates

IBT is committed to transparency and will review this policy periodically. Should circumstances change, this policy will be updated accordingly. All changes will be published on our website.

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For further information, please reach out to IBT at info@ibtherapeutics.com.