Recent News 56 : Concerns with delivery device prompt FDA to pause BiomX's cystic fibrosis study

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Concerns with delivery device prompt FDA to pause BiomX's cystic fibrosis study

Ref: GlobeNewswire

The FDA has placed a clinical hold on a Phase IIb study of BiomX's experimental multi-phage cocktail in patients with cystic fibrosis. 

The pause was triggered by concerns with a third-party nebuliser used to deliver BX004, BiomX said Tuesday. The regulator did not identify any issues with the phage therapy itself, which is designed to target chronic pulmonary infections caused by Pseudomonas aeruginosa. 

Calling the hold "temporary," BiomX said it has submitted data regarding the nebuliser that is expected to provide the FDA with the information it's requested.  

"We are actively engaged with the FDA to promptly address their queries regarding the third-party nebulizer," said CEO Jonathan Solomon. "We remain optimistic and confident that in response to the hold, we have provided the FDA with data that can satisfactorily support the use of the nebulizer and that this can be resolved promptly so that we may resume treating patients with cystic fibrosis in the US."

While patient screening and enrolment in the US portion of the study have been paused, clinical activities are still underway in the EU, where all components of the third-party nebuliser device are CE marked, meeting applicable regulatory requirements.


Copyright, taken from, https://firstwordpharma.com/story/5990533

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