Appili Therapeutics Inc., a biopharmaceutical company focused on anti-infective drug development, has entered into a commercialization agreement with Saptalis Pharmaceuticals LLC, a specialty pharmaceuticals company, for ATI-1501, Appili’s liquid suspension reformulation of the antibiotic metronidazole. Appili is eligible to receive multiple milestone and royalty payments on the sale of ATI-1501 in the U.S. Saptalis will be responsible for overseeing the regulatory review, manufacturing and preparation for the anticipated commercialization of ATI-1501 in the U.S.

​​ATI-1501 is a novel, taste-masked oral liquid formulation of metronidazole, a broad-spectrum antibiotic used to treat parasitic and anaerobic bacterial infections. Currently, oral metronidazole is only available as a solid tablet or capsule in the U.S. and Canada; no liquid oral dose forms are approved. The tablet’s bitter taste is so pronounced that it appears as an adverse event on the drug’s label. Appili began developing ATI-1501 to solve a significant and growing issue for patients who cannot tolerate the current tablet formulation of metronidazole.

“Infectious diseases form the basis of some of the most urgent public health threats in today’s treatment landscape. Our approach to drug development is to identify overlooked infectious disease assets that address significant needs in the marketplace, and advance them through the drug development process,” said Dr. Armand Balboni, chief executive officer, Appili Therapeutics. “Having completed clinical development for ATI-1501 at Appili, we are pleased to find a strong partner who can take the program through FDA review and market launch, upon regulatory approval. This agreement with Saptalis is a win for our shareholders, clinicians and patients seeking better treatment options.”

“We are excited to form a partnership with Appili on their ATI-1501 program, which is a good fit for Saptalis’ focus on developing difficult-to-formulate dosage forms and novel drug delivery approaches, including liquid suspensions,” said Polireddy Dondeti, PhD, chief executive officer at Saptalis Pharmaceuticals, LLC. “We have a great team and a great facility here at Saptalis with the resources to efficiently manufacture the product to commercial scale, to complete regulatory review and, ultimately, to launch the antibiotic in a timely fashion.”