Appili Therapeutics plans to use data from clinical study for a New Drug Application

Halifax-based Appili Therapeutics Inc. announces that they have received positive top-line results from a pivotal relative bioavailability study evaluating pharmacokinetics, safety, and palatability of ATI-1501 in healthy, normal adults. The company plans on using the data from this study to file a New Drug Application (NDA) with the US Food & Drug Administration (FDA) for ATI-1501 in early 2019. ATI-1501 is a proprietary, taste-masked oral suspension formulation of the antibiotic metronidazole, which is broadly prescribed to treat parasitic and anaerobic bacterial infections that tend to affect the elderly population.

The clinical study results showed that a single 500 mg dose of ATI-1501 achieved equivalent systemic drug levels to a 500 mg metronidazole tablet under fasted and fed conditions. ATI-1501 was well tolerated and safety observations for ATI-1501 were consistent with the known safety profile of metronidazole.

“Appili Therapeutics set out to address an unmet medical need – namely to provide an alternative antibiotic solution for patients with difficulty swallowing. Our clinical data demonstrate that ATI-1501 has an acceptable safety profile while being more palatable than metronidazole tablets for a vulnerable patient population,” says Jamie Doran, MSc, DABT, ERT, vice president of Drug Development for Appili. “As we move towards a submission to the FDA for market approval, we anticipate that ATI-1501 will soon be available to healthcare providers and caregivers as an excellent alternate treatment option for those with serious infections requiring treatment with metronidazole.”

In many countries, including the US and Canada, oral metronidazole is only available in tablet forms; and for patients who have difficulty swallowing, the patients themselves or caregivers must crush the drug and add it to food prior to ingestion This process increases risk for dosing error and magnifies the pronounced bitter taste of metronidazole that can negatively impact patients’ ability to comply with their full treatment regimen. The bitter taste of metronidazole is so noticeable that it is listed as an adverse event on the drug label. ATI-1501 has been designed to offer patients with difficulty swallowing the drug a more palatable, easy-to-take liquid suspension alternative.