Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Appili Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for ATI-1501, a taste-masked reformulation of metronidazole with the potential to treat Clostridium difficile infection (CDI) in children.
Subscribe to our email newsletter
ATI-1501 is the company’s lead drug candidate, which is expected to enter into clinical trials by 2017.
The orphan drug status offers seven years of marketing exclusivity after approval of ATI-1501, reduced FDA application and administration fees and tax credits for clinical research in the US.
Appili Therapeutics CEO Kevin Sullivan said: "The bitter metronidazole tablet is highly unpalatable for most children, so ATI-1501 has the potential to fundamentally improve compliance rates for these patients who are in need of a safe and effective treatment for CDI."
CDI affects more than half a million Canadians and Americans every year.
It reoccurs in 83,000 patients and is responsible for 29,000 deaths per year. The incidence of CDI in children has been increasing steadily in recent years.
Appili’s second product, ATI-1503, is a novel antibiotic with the potential to treat deadly infections like Klebsiella pneumoniae.
The US Center for Disease Control identified the drug-resistant Gram-negative bacterial infections, CDI and Klebsiella pneumoniae, as posing the highest threat to human health.