Amplyx Pharmaceuticals

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Presentation of data from multiple preclinical studies from APX001 antifungal program

SAN DIEGO – April 12, 2019 – Amplyx Pharmaceuticals, a company developing first-in-class products for life-threatening infections, announced today that three posters from the APX001 development program will be presented at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), being held in Amsterdam, Netherlands, from April 13 to 16, 2019.
The Company and its collaborators will present data from its APX001 preclinical programs in both oral and poster presentations at the conference. APX001 is a broad-spectrum antifungal drug with a novel mechanism of action for the treatment of life-threatening, invasive fungal infections caused by Candida – including Candida auris – Aspergillus and by rare, hard-to-treat molds, including strains that are resistant to standard of care antifungal therapy. Currently, multiple Phase 2 proof of concept studies of APX001 are being conducted in patients with invasive candidiasis/candidemia, invasive aspergillosis and C. auris. Completed Phase 1 clinical trials have determined the safety, tolerability, and pharmacokinetics of the intravenous and oral formulations of APX001.

The details for the data presentations at ECCMID are as follows:
Title: In vitro activity of APX001A and comparator agents against 1706 fungal isolates collected
during an international surveillance programme (2017)
Date and time: Saturday, April 13 from 2:45 – 3:45 p.m. CEST Session type: 1-Hour Oral Session
Location: Hall N Presentation number: #O0269 Session: Novel approaches to fungal diseases
Title: APX001 protects immunosuppressed mice from scedosporiosis Date and time: Monday, April 15 from 11:00 – 12:00 p.m. CEST Session type: Mini-oral ePoster session
Location: Arena 2 Presentation number: #O0734 Session: Antifungals: novel drugs, novel dosing?
Title: In vivo pharmacodynamic evaluation of the novel antifungal agent APX001 in a murine model of invasive pulmonary aspergillosis against wild-type and Cyp51 mutant Aspergillus fumigatus
strains Date and time: Tuesday, April 16 from 11:00 – 12:00 p.m. CEST Session type: Mini-oral ePoster session
Location: Arena 2 Presentation number: #O1066 Session: Defining exposure, efficacy and safety of new antimicrobial agents
Full abstracts can be found on the ECCMID website at www.eccmid.org.

About APX001

APX001A, the active moiety of APX001, inhibits the highly conserved fungal enzyme Gwt1, compromising growth of major fungal pathogens. In multiple nonclinical studies, APX001 has shown broad-spectrum activity against common species of Candida spp. and Aspergillus spp., including multi-drug resistant strains including Candida auris and rare, hard-to-treat molds including Fusarium spp., Scedosporium spp., and fungi from the Mucorales order. APX001 is currently in Phase 2 clinical trials evaluating the efficacy and safety of both IV and oral APX001 for the first-line treatment of patients with fungal infections.

Invasive infections due to Aspergillus, Fusarium, Scedosporium and fungi from the Mucorales order are especially difficult to treat resulting in high mortality rates (50-80%), even when patients receive standard of care treatment. The frequency of fungi resistant to both the azole and echinocandin classes of drugs is increasing. Thus, there remains a significant unmet medical need for a new broad-spectrum antifungal to treat serious, invasive fungal infections and reduce the existing high morbidity and mortality.

About Amplyx Pharmaceuticals

Amplyx Pharmaceuticals is developing first-in-class products for life-threatening infections, with a near-term focus on deadly fungal pathogens in vulnerable patients. Amplyx’s drug discovery and development efforts have been supported by significant venture investment and grants from the National Institutes of Health.

Contact:
Heidi Chokeir, Ph.D.
Managing Director
Canale Communications
(619) 849-5377 heidi@canalecomm.com
Investor Contact:
Mary Gieson
Amplyx Pharmaceuticals, Inc.
(858) 876-6534 mgieson@amplyx.com