Appili Therapeutics Acquires FUJIFILM’s Novel Antifungal Candidate ATI-2307 for Cryptococcal Meningitis Development

VCBeat (WeChat ID: vcbeat) learned from foreign media that on November 21, 2019, local time, Appili Therapeutics (“Appili”), a biopharmaceutical company focused on the development of anti-infective drugs, announced the acquisition of ATI-2307, a novel clinical-stage antifungal drug, from FUJIFILM Toyama Chemical (“FUJIFILM”). This drug is a new broad-spectrum antifungal agent that has been evaluated in multiple preclinical studies and three Phase I clinical trials in humans.

Under the agreement, Appili will obtain exclusive global (excluding Japan) rights to develop and commercialize ATI-2307. FUJIFILM will receive from Appili related future regulatory and commercial milestone payments, as well as royalties on future net sales.

FUJIFILM was formed through the merger of FUJIFILM RI Pharma and TOYAMA CHEMICAL. The former is primarily engaged in the development and commercialization of radiopharmaceuticals, while the latter focuses on the development and commercialization of small-molecule drugs. The merged company concentrates on therapeutic areas including oncology, central nervous system disorders, and infectious diseases.

ATI-2307 is a novel broad-spectrum antifungal agent with a highly differentiated mechanism of action that, in prior studies, has demonstrated resilience against existing resistance mechanisms. It exhibits broad-spectrum antifungal activity both in vitro and in vivo against various high-priority and clinically significant fungi, including Cryptococcus species and multidrug-resistant Candida species. Currently, ATI-2307 is in clinical development and has completed three Phase I clinical trials. These studies have shown that the candidate drug is well tolerated in humans at the anticipated therapeutic dose levels.

“Appili’s mission is to identify, acquire, and develop the most promising anti-infective technologies. The acquisition of ATI-2307 will rapidly enhance the company’s value, marking an exciting step forward,” said Kevin Sullivan, CEO of Appili.

Junji Okada, President and Chief Operating Officer of FUJIFILM, stated: “FUJIFILM is pleased to enter into this agreement with Appili. Appili has demonstrated deep expertise in accelerating the development of anti-infective drugs, which aligns closely with FUJIFILM’s focus on innovative research and development in the field of infectious diseases. FUJIFILM is committed to addressing public health challenges through innovation, high-value drug development, and value-added partnerships. We believe that Appili is the right partner to maximize the potential of ATI-2307 and combat difficult-to-treat invasive fungal infections.”

Appili, founded in 2015 and headquartered in Nova Scotia, Canada, is an anti-infective drug development company. The company initially planned to develop ATI-2307 for the treatment of cryptococcal meningitis. Cryptococcal meningitis is an opportunistic fungal infection and one of the leading causes of fatal disease worldwide. Although effective treatments are currently available, the acute mortality rate among hospitalized patients with cryptococcal meningitis remains high. The current standard of care, which involves amphotericin B combined with flucytosine, is associated with significant toxicity and can lead to severe adverse outcomes such as potential renal failure.

Dr. Armand Balboni, Chief Development Officer at Appili Therapeutics, stated, “For many patients, current standard-of-care antifungal agents are toxic and exhibit poor efficacy. The rising resistance to antifungal drugs and the emergence of intrinsically resistant pathogens may further limit already inadequate antifungal treatment options. Furthermore, with an aging population and the widespread use of immunosuppressive therapies, patients face an increasing risk of fungal infections, which are becoming more difficult to treat. This trend places a significant strain on hospital resources and contributes to higher patient morbidity and mortality.”

Dr. Armand Balboni continued, “We believe ATI-2307 has great potential to provide a more effective and safer treatment option for patients with invasive fungal infections.”

(Compiled by: He Li)