Upcoming PDUFA date of September 23, 2023
Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced that the United States Patent and Trademark Office (“USPTO”) has published patent claims for ATI-1501 under the U.S. Application No. 18/072,154 filed on November 30, 2022 and titled “Oral Formulations of Metronidazole and Methods of Treating an Infection Using Same”. The patent covers the composition and preparation methods for the drug through 2039.
Metronidazole is a widely used frontline oral treatment with over 10 million 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 U.S. market, but its bitter taste and lack of appropriate dosage forms for patients with difficulty swallowing often presents treatment compliance challenges.
“We believe our liquid oral reformulation solves a significant and growing issue for patients who cannot tolerate the current tablet formulation of metronidazole, especially for the elderly and children who often have difficulty taking solid oral medicines” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili Therapeutics. “This patent recognizes innovative research by Appili Therapeutics to fill this significant gap in the treatment paradigm, and further strengthens ATI-1501’s position as a more convenient antibiotic treatment option on the market. The market potential is significant and receiving this patent coverage prior to the upcoming FDA PDUFA date of September 23, 2023, should provide our oral reformulation metronidazole drug market exclusivity through at least 2039.”
The FDA established ATI-1501 a Prescription Drug User Fee (“PDUFA”) action date of September 23, 2023.
About Appili Therapeutics
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. For more information, visit www.AppiliTherapeutics.com.
Forward looking statements
This news release contains “forward-looking statements”, including with respect to the proposed development and commercialization plans for ATI-1501 and the atnicipated PDUFA date. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. Forward looking statements contained in this press release are provided in reliance on certain assumptions, including with respect to the FDA application and approval process for ATI-1501. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company cannot give assurance that these expectations will prove to have been correct.
Forward looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the risk that the New Drug Application for ATI-1501 may ultimately not be approved by the FDA, and the other risk factors listed in the annual information form of the Company dated June 23, 2022 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.