US FDA Accepts the ATI-1501 NDA, According to Appili Therapeutics
13 February 2023 - - The Food and Drug Administration accepted the ATI-1501 New Drug Application, Canada-based biopharmaceutical company Appili Therapeutics Inc. (TSX: APLI), with its partner Saptalis Pharmaceuticals LLC, said.

ATI-1501 is Appili's liquid oral reformulation of the antibiotic metronidazole, which has been licensed to Saptalis. The FDA established a Prescription Drug User Fee action date of September 23, 2023.

Metronidazole is a widely used frontline oral treatment with over 10 m prescriptions written in the United States every year to help treat parasitic and anaerobic bacterial infections.

The current tablet form of metronidazole is the only approved oral form on the US market and its bitter taste and lack of appropriate dosage forms prove highly difficult for patients with trouble swallowing, presenting frequent treatment compliance challenges.

Approval of ATI-1501 will unlock the potential to achieve relief and recovery for the millions facing these devastating infections by offering a convenient treatment option.

ATI-1501 is a proprietary taste-masked liquid suspension reformulation of metronidazole. Metronidazole is a widely used front-line oral treatment with over 10m prescriptions written in the United States every year and is used to treat parasitic and anaerobic bacterial infections, which heavily burden elderly patients.

The bitter taste of metronidazole and lack of appropriate dosage forms for patients with difficulty swallowing presents treatment compliance challenges, which ultimately can lead to detrimental effects on patient outcomes, healthcare costs, infection control, and antibiotic resistance.

ATI-1501 is designed to enable broader use of metronidazole and provide a solution with the same safety and efficacy profile provided by metronidazole for 50 years, that is both easy to swallow and good tasting, thereby helping patients to adhere with their medication and improve their prognoses.

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections.

By systematically identifying urgent infections with unmet needs, Appili's goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives.

The company is currently advancing a diverse range of anti-infectives, including a vaccine candidate to eliminate a serious biological weapon threat, a topical antiparasitic for the treatment of a disfiguring disease, and a novel easy to use, liquid oral formulation targeting parasitic and anaerobic infections.

Led by a proven management team, Appili is at the epicenter of the global fight against infection.

Saptalis Pharmaceuticals is a pharmaceutical company specialized in development, manufacturing, and commercialization of generic and innovative products in liquid and semi-solid dosage forms.

Located in the Hauppauge Industrial Park on Long Island, NY, USA, Saptalis has fully equipped Research & Development Laboratories and state of the art commercial scale manufacturing facility designed to meet FDA cGMP requirements.