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.
Mabwell's B7-H3-targeting ADC clinical trial application receives Chinese regulatory approval
Dupixent receives approval in Japan as first biologic for COPD treatment
Vast Therapeutics' ALX1 drug candidate granted QIDP designation by US FDA
Actinium Pharmaceuticals signs Ac-225 radioisotope agreement with Eckert & Ziegler
GSK's Nucala (Mepolizumab) COPD application accepted by EMA
Everest Medicines' EVM14 IND application receives US FDA approval
Clover Biopharmaceuticals' SCB-1019 IND application receives US FDA approval
CStone Pharmaceuticals submits Type II variation application to EMA for sugemalimab
Hikma announces Health Canada approval of KLOXXADO Nasal Spray for opioid overdose treatment
Johnson & Johnson reports breakthrough overall survival data for EGFR-mutated lung cancer treatment
Altesa BioSciences granted US regulatory approval for vapendavir clinical trials
Black Diamond Therapeutics and Servier agree global licensing deal for BDTX-4933
AstraZeneca secures EU approval for Imfinzi in limited-stage small cell lung cancer