The first drug candidate of Appili Therapeutics, an anti-infective drug development company, has been cleared to begin clinical trials in both Canada and the U.S.

The Halifax company said in a press release today that the Food and Drug Administration in the U.S. has cleared the company’s IND application to conduct a clinical trial of its compound ATI-1501. Similarly, Health Canada has given the drug CTA clearance, and the company hopes to have the drug on the market next year.

Appili, which announced a $3.1 million funding round last week, plans to conduct the ATI-1501 clinical study in Toronto and will begin recruiting subjects in November. The company expects to enroll about 40 healthy volunteers in this bioavailability study.

“Having both Health Canada and FDA authorization affirms our confidence in our regulatory and development strategy,” said Appili CEO Kevin Sullivan in the statement. “We’re excited to take ATI-1501 into clinical trials because it brings us a step closer to offering physicians a new weapon to fight serious infections and improve patient compliance.”

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Appili last year revealed a two-track strategy. In the next few years it is working to bring to market ATI-1501, which treats clostridium difficile infection, or CDI, in children.

ATI-1501 removes the bitter taste from Metronidazole, a drug that has been used to treat the condition since the 1970s. Metronidazole is effective, but it tastes awful, so children often won’t take it, thereby limiting its effectiveness. By removing the bitter taste, ATI-1501 improves the results of the drug.

CDI is one of the U.S. Centers for Disease Control’s most urgent antibiotic-resistant bacterial threats. It affects more than 500,000 Canadians and Americans each year and causes 29,000 deaths annually. The Food and Drug Administration has granted orphan drug designation to the drug, reducing the regulatory burden in launching the drug.

Meanwhile, Appili is also working on ATI-1503, an antibiotic that could fight deadly infections such as Klebsiella pneumonia. CEO Kevin Sullivan has said the drug could combat viruses that are resistant to antibiotics, but it’s a longer-term, riskier project than the first drug.

“We expect the completion of this clinical trial will set us up to file our new drug application in 2018 and advance our commercialization activities,” said Jamie Doran, Vice President of Drug Development.