Clinical-stage life science company Vast Therapeutics announced on Tuesday that the US Food and Drug Administration has granted its ALX1 drug candidate 'Qualified Infectious Disease Product'(QIDP) designation.
This incentive programme is intended to promote the development of antibacterial drugs to treat serious or life-threatening infections, such as those caused by Pseudomonas aeruginosa, a gram-negative bacterium that typically infects people in the hospital or with weakened immune systems and is particularly problematic for patients with chronic lung diseases.
Clinical evidence shows that people with certain chronic respiratory diseases have significantly reduced nitric oxide production that affects their ability to mount an effective defence against microbial challenges and an inability to regulate the resulting inflammation. Vast Therapeutics' lead candidate, ALX1, is a first-in-class small molecule drug product designed to efficiently restore nitric oxide levels in the lung. Delivered via a hand-held, portable inhalation device, ALX1 is nebulised daily as a fine mist into the lungs. This dual mechanism of action treatment targets the vicious cycle of infection and inflammation in these patients.
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Vast Therapeutics' ALX1 drug candidate granted QIDP designation by US FDA