Amplyx to Present New Clinical and Preclinical Data for its Two Lead Programs at Upcoming Scientific Conferences

SAN DIEGO, Oct. 16, 2020 /PRNewswire/ --Amplyx Pharmaceuticals, a clinical-stage biopharmaceutical company developing innovative therapies for debilitating and life-threatening diseases in patients with compromised immune systems, announced today that new clinical and preclinical data for its Phase 2 programs, fosmanogepix and MAU868, will be presented at IDWeek 2020 and at the American Society of Nephrology (ASN) Kidney Week 2020.  Both conferences will take place virtually.

At IDWeek 2020, positive data from the Phase 2 clinical trial evaluating fosmanogepix, a novel IV and oral Gwt1 inhibitor, in patients with candidemia will be presented during an oral session by Peter G. Pappas, M.D. of the University of Alabama at Birmingham. Top line data from this trial was first announced earlier this year. Additional fosmanogepix clinical and preclinical data will also be presented at separate poster sessions, including a subset analysis of Phase 2 patients with renal insufficiency. In addition, data on Amplyx's preclinical oral Gwt1 inhibitor with highly potent activity against Cryptococcus, APX2039, will be presented at the conference. Details are as follows:

ID Week 2020
Oral Presentations:
Title: "Clinical Safety and Efficacy of Novel Antifungal, Fosmanogepix, in the Treatment of Candidemia: Results from a Phase 2 Proof of Concept Trial"
Presenter: Peter G. Pappas, University of Alabama at Birmingham
Session: Innovations and Updates in Mycology
Date:  October 21, 2020, On Demand

Title: "Efficacy of the Novel Gwt1 Inhibitor APX2039 in a Rabbit Model of Cryptococcal Meningitis"
Presenter: Charles D. Giamberardino, Jr., Duke University
Session: Novel Agents
Date:  October 21, 2020, On Demand

ePoster Presentations:
Title: "Clinical Safety, Efficacy, and Pharmacokinetics of Fosmanogepix, a Novel First-in-Class Antifungal, in Patients with Renal Insufficiency: Subset Analysis from a Phase 2 Candidemia Trial"
Poster ID: 1157
Presenter: Pierre Bulpa, Mont-Godinne University Hospital
Session: Medical Mycology
Date:  October 21, 2020, On Demand

Title: "Activity of Manogepix (APX001A) against 2,669 Fungal Isolates from the SENTRY Surveillance Program (2018-2019) Stratified by Infection Type"
Poster ID: 1260
Presenter: Michael D. Huband, JMI Laboratories
Session:  Novel Agents
Date: October 21, 2020, On Demand

Title: "Evaluation of in vitro Activity of Manogepix against Multidrug-resistant and Pan-resistant Candida auris from the New York Outbreak"
Poster ID: 1275
Presenter:  Karen J. Shaw, Hearts Consulting Group
Session:  Novel Agents
Date:  October 21, 2020, On Demand

Title: "Manogepix, the Active Moiety of the Investigational Agent Fosmanogepix, Demonstrates in vitro Activity Against Members of the Fusarium oxysporum and Fusarium solani Species Complexes"
Poster ID: 1282
Presenter:  Nathan P. Wiederhold, University of Texas San Antonio
Session:  Novel Agents
Date:  October 21, 2020, On Demand

At the American Society of Nephrology (ASN) Kidney Week 2020, clinical and preclinical data on Amplyx's novel anti-BKV monoclonal antibody, MAU868, will be presented.  MAU868 is currently in Phase 2 clinical development. Details are as follows:  

Kidney Week 2020
ePoster Presentations:
Title: "A First-in-Human Study of MAU868, a Novel Neutralizing Antibody Against BK Virus"
Abstract ID: PO2455
Presenter: Steven J. Kovacs, Novartis Institutes for BioMedical Research
Session: Transplant Complications: Infection
Date and Time: October 22, 2020, 10:00 AM-12:00 PM ET, On Demand

Title: "Preclinical Characterization of MAU868, a Novel Neutralizing Antibody Targeting BK Virus"
Abstract ID: PO2367
Presenter: Atul Sathe, Novartis Institutes for BioMedical Research
Session: Pharmacology
Date and Time: October 22, 2020, 10:00 AM-12:00 PM ET, On Demand

About Fosmanogepix
Fosmanogepix, is a novel, broad-spectrum antifungal agent being evaluated in multiple clinical trials in patients with life-threatening fungal infections.  Fosmanogepix demonstrated a high level of treatment success (80%) in a Phase 2, proof-of-concept study as first-line treatment of infections caused by Candida.  Additional Phase 2 studies of fosmanogepix are ongoing in patients with Aspergillus and rare mold infections, as well as infections caused by multi-drug-resistant Candida auris, a life-threatening fungal infection recently characterized as an "urgent" threat by the Centers of Disease Control (CDC).

Fosmanogepix has a novel mechanism of action, and its active moiety has shown broad-spectrum activity against common species of Candida and Aspergillus, including multi-drug resistant strains, such as C. auris and C. glabrata, as well as rare, hard-to-treat molds including Fusarium, Scedosporium and some fungi from the Mucorales order. Invasive fungal infections result in high mortality rates (30-80%), despite standard-of-care treatment. The frequency of fungi resistant to both the azole and echinocandin classes of drugs is increasing and there is a significant unmet medical need for a new, broad-spectrum antifungal agent.

Fosmanogepix has received Fast Track and Orphan Drug designations from the US FDA for seven separate indications and is also designated as a Qualified Infectious Disease Product (QIDP) for the treatment of four indications.

About MAU868
MAU868, a novel human monoclonal antibody that potently neutralizes the BK virus, which can cause significant morbidity and mortality in transplant patients.  Antibodies to BKV are found in approximately 80 to 90% of adults worldwide, indicating previous infection or exposure to the virus. A weakened immune system may result in BKV reactivation and cause serious disease. In patients who have had kidney transplant, BKV can lead to the loss of the transplanted kidney. BKV reactivation in the bladder can also cause hemorrhagic cystitis. Severe cases require bladder irrigation, clot evacuation, blood transfusion, stenting and nephrostomy. There are currently no approved treatments for renal nephropathy or hemorrhagic cystitis caused by BKV.

MAU868 potently neutralizes all four major genotypes of BKV at sub-nanomolar concentrations and has a high barrier to resistance in vitro.  MAU868 also has neutralizing activity against the closely related JC virus, the cause of progressive multifocal leukoencephalopathy

MAU868 is currently being evaluated in a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical trial to assess the safety, pharmacokinetics, and efficacy for the treatment of BK viremia in kidney transplant recipients at centers in the US and Canada. The study's primary objectives are to assess the safety of MAU868 in this patient population and to evaluate the efficacy of MAU868 in reducing BKV plasma viral load.   

About Amplyx Pharmaceuticals
Amplyx Pharmaceuticals is developing innovative therapies for patients with compromised immune systems, including cancer and transplant patients, and the critically ill. The company's two lead products are fosmanogepix (APX001), a first-in-class antifungal, for the treatment of life-threatening fungal infections caused by pathogens such as Candida, Aspergillus and rare molds, and MAU868, a novel human monoclonal antibody that potently neutralizes the BK virus, which can cause significant morbidity and mortality in transplant patients. For more information, please visit www.amplyx.com

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