Expanded access policy for SNIPR001 investigational product 

 

This policy provides guidance for how to seek access to SNIPR001 through an Expanded Access Program (EAP). 

At SNIPR Biome we believe that the most appropriate way patients can access investigational medicines is through a clinical trial. Overseen by a team of medical experts, clinical trials are designed to determine whether an investigational medicine is safe and effective for patients. Data generated by clinical trials provide regulatory authorities with essential information needed to evaluate a medicine. Only after reviewing this information will regulators approve a new medicine, allowing it to be widely available. 

In rare cases, however, when a patient does not qualify for a clinical trial and have exhausted other available medical options, SNIPR Biome may consider providing our investigational product SNIPR001 through an EAP to US based patients.  

A request by the patients US-licensed treating physician can be made if the following conditions are met: 

  • The patient has a serious or life-threatening condition where E. coli is the causative pathogen. 

  • The patient has undergone appropriate standard treatments without success and there is no satisfactory alternative treatment available. 

  • The patient is ineligible or unable to participate in a clinical trial using SNIPR001. 

  • The potential benefit to the patient outweighs the potential risks. 

  • The patient and the treating physician are both based in the US. 

SNIPR Biome may not be able to provide expanded access to all requesting physicians and patients. Factors that may lead to a denial of expanded access may include: availability of product; applicable country or other rules and regulations prohibiting the supply of product; customs and import restrictions into the requesting country or jurisdiction; lack of medical expertise; and patients not meeting the inclusion criteria or taking other drugs that prohibit the use of the product. Other limiting factors may also apply. 

To submit a request for expanded access to SNIPR001 the treating physician can contact SNIPR Biome: access@sniprbiome.com. We will strive to acknowledge the receipt of the request within 5 business days. 

 

You may also learn more about ongoing clinical trials by going to www.clinicaltrials.gov and searching for SNIPR001. 

 

As authorized by the 21st Century Cures Act, SNIPR Biome may revise this Expanded Access Policy at any time. The posting of this policy by SNIPR Biome shall not serve as a guarantee of access to any specific investigational medicine by any individual patient.