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.
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
Akeso's Penpulimab receives Chinese regulatory approval
Korro Bio receives FDA orphan drug designation for KRRO-110
Health Canada approves Johnson & Johnson therapy for advanced EGFR-mutated lung cancer
Polarean expands Xenon MRI imaging for pharma-sponsored research
Celltrion's OMLYCLO receives US FDA approval
Health Canada approves ALK's ACARIZAX for young children with dust mite allergy
Plus Therapeutics secures FDA Orphan Drug Designation for Rhenium (186Re) Obisbemeda
CStone Pharmaceuticals reports first patient dosed in CS2009 Phase I trial