Market Overview

Appili Therapeutics Completes Phase 1 Study for ATI-1501, Its Taste-Masked Oral Metronidazole Suspension, Demonstrating Significant Improvements in Taste and Palatability

Share:

New Antibiotic Formulation Designed to Treat Parasitic and Anaerobic
Bacterial Infections; Appili Will Use Study Data as Basis for NDA Filing

Appili Therapeutics Inc. (the "Company" or "Appili") announced today
positive top-line results of a pivotal relative bioavailability study
evaluating pharmacokinetics, safety, and palatability of ATI-1501 in
healthy, normal adults. Data from this study will be used 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
heavily burden the elderly.

The clinical study results announced today 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," said 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 solid forms. Patients with difficulty swallowing the
oral tablet require pharmacists, the patients themselves or caregivers
to crush the drug and add it to food prior to patients ingesting it.
This process increases risk for dosing error and amplifies 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 pronounced 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.

About the Bioavailability Study

The primary objective of the randomized, open-label, single-dose,
two-sequence, cross-over clinical study was to assess the relative
bioavailability of ATI-1501 compared to the reference product Flagyl®
(solid metronidazole tablets) under fasted and fed conditions.
Clinicians performed the study under an Investigational New Drug
application (IND) and a Clinical Trial Application (CTA) approved,
respectively, by the US Food and Drug Administration and Health Canada
in 2017. A total of 44 healthy adults aged 18 to 63 years completed the
study.

A planned subset of participants was also asked to evaluate the taste
properties and relative preference for ATI-1501 compared to
metronidazole crushed in applesauce, which is the current standard of
care for elderly and pediatric patients with difficulty swallowing.
Palatability measures were assessed using the 9-point hedonic scale, the
most widely recognized and used scale to measure taste preference and
selection in the food industry. A total of 25 participants participated
in this palatability and preference component, ranging from 18 to 63
years of age. ATI-1501 exhibited meaningful and statistically
significant improvements across all palatability measures (taste,
bitterness, smell, texture) compared to crushed tablets with a
corresponding reduction in bitterness scores and a strong preference for
ATI-1501 over the current standard of care.

Based on these findings, Appili expects to submit complete study results
for publication in a peer-reviewed medical journal.

"We are currently pursuing commercial manufacturing activities to
support an NDA filing in the first quarter of 2019," said Appili CEO
Kevin Sullivan, MBA. "In addition, we are actively engaged in
commercialization and licensing activities to maximize patient access to
ATI-1501 in US and global markets."

About Appili Therapeutics

Appili Therapeutics, Inc., was founded to advance the global fight
against infectious disease by matching clearly defined patient needs
with drug development programs that provide solutions to existing
challenges patients, doctors and society face in this challenging
disease space. Balancing near-to-market product candidates with
higher-risk but potentially transformative early-stage programs,
Appili's growing pipeline includes assets being developed by Appili as
well as an active licensing program. ATI-1501 employs Appili's
proprietary, taste-masked, oral-suspension technology with metronidazole
for the growing number of pediatric and elderly patients with difficulty
swallowing. ATI-1503 is a drug discovery program aimed at generating
negamycin analogue candidates, a novel class of antibiotics with
broad-spectrum activity against Gram-negative bacteria. Via an
in-licensing program, Appili acquired the rights to ATI-1701, a vaccine
for tularemia, removing risk from a weaponized bioterrorism pathogen.
Headquartered in Halifax, Nova Scotia, with offices in Mississauga,
Ontario, Appili is pursuing worldwide opportunities in collaboration
with science and industry commercial partners, governments and
government agencies. For more information, visit www.AppiliTherapeutics.com.

View Comments and Join the Discussion!