Canadian company gets US approval for pediatric CDI drug
Appili Therapeutics Inc. of Halifax announced Tuesday it has received a key U.S. regulatory designation for a drug that treats Clostridium difficile infection in children.
The company said in a statement the Food and Drug Administration has granted orphan drug designation to its drug candidate ATI-1501. This medicine removes the bitter taste from a long-standing drug so that children are more willing to take it, thereby improving its effectiveness.
It is the latest step for a young company that has created excitement in the region’s biotech community. Appili was formed last year when CEO Kevin Sullivan, one of the most experienced biotech execs in the region, partnered with Bloom Burton & Co., a Toronto investment bank specializing in healthcare. Together, they formed a company to identify promising drug candidates and take them to development, including ATI-1501.
“In just three months, we received orphan drug designation from the FDA,” said Sullivan in a statement. “Having this quick turnaround is an indication of the high quality of the regulatory team we have built, and an important step on our path to becoming the first company to offer an approved treatment for C. difficile designed specifically for children affected by this serious infection.”