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
Title: "Efficacy of the Novel Gwt1 Inhibitor APX2039 in a Rabbit Model of Cryptococcal Meningitis"
Title: "Activity of Manogepix (APX001A) against 2,669 Fungal Isolates from the SENTRY Surveillance Program (2018-2019) Stratified by Infection Type"
Title: "Evaluation of in vitro Activity of Manogepix against Multidrug-resistant and Pan-resistant Candida auris from the New York Outbreak"
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"
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
Title: "Preclinical Characterization of MAU868, a Novel Neutralizing Antibody Targeting BK Virus"
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.
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
View original content to download multimedia:http://www.prnewswire.com/news-releases/amplyx-to-present-new-clinical-and-preclinical-data-for-its-two-lead-programs-at-upcoming-scientific-conferences-301153828.html
SOURCE Amplyx Pharmaceuticals