Management
Our Products
Fosmanogepix (APX001)
Fosmanogepix is a novel antifungal therapy with broad spectrum activity. Fosmanogepix is currently in Phase 2 clinical trials evaluating the efficacy and safety of both intravenous and oral formulations for the treatment of patients with fungal infections. Manogepix (APX001A), the active moiety of fosmanogepix (APX001), inhibits the highly conserved fungal enzyme Gwt1, compromising growth of fungal pathogens. The novel mechanism of action of fosmanogepix translates into a highly versatile drug that demonstrates activity against drug-resistant strains and can be delivered in both oral and intravenous formulations. In multiple nonclinical studies, manogepix has shown broad-spectrum activity against common species of Candida spp. and Aspergillus spp., including multi-drug resistant strains, such as C. auris and C. glabrata, as well as rare, hard-to-treat molds including Fusarium spp., Scedosporium spp., and fungi from the Mucorales order.
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.
MAU868
MAU868 is a novel human monoclonal antibody (immunoglobulin G, IgG1) that potently neutralizes all four BKV serotypes. MAU868 also neutralizes the closely related JC virus. MAU868 binds the viral capsid protein, VP1, which is responsible for binding to the surface of host cells. It recognizes a conformational epitope on VP1 that is highly conserved, resulting in a high barrier to resistance in vitro. MAU868 is being developed for the prevention and treatment of clinically significant BKV infection in kidney transplant and hematopoietic stem cell transplant patients.
Antibodies to BKV are found in approximately 80 to 90 percent of adults worldwide, indicating previous infection or exposure to the virus. Initial infection with BKV is usually asymptomatic or associated with a mild flu-like illness. After primary infection, BKV remains inactive, or latent, in kidney and bladder cells. A weakened immune system may give the virus a chance to reactivate and cause serious disease. In patients who have had kidney transplant, BK viral disease results in nephropathy and potential loss of graft function. In the absence of effective treatment, reduction of immunosuppression is recommended, but this ironically can lead to acute organ rejection. BKV re-activation can also occur after hematopoietic stem cell transplants, resulting in hemorrhagic cystitis, the symptoms of which include painful urination, blood in the urine and hemorrhage. Severe cases require bladder irrigation, clot evacuation, blood transfusion, stenting and nephrostomy. There are currently no approved treatments for BKV- associated disease.
Pipeline
Expanded Access
Amplyx is committed to developing safe and effective first-in-class products for the treatment of life-threatening diseases in immunocompromised patients. Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for patients.
Amplyx believes that the most appropriate mechanism to access investigational therapies is in the context of a clinical trial. We recognize, however, that there are circumstances that may arise that prohibit a patient’s participation in a clinical trial. At this time, Amplyx’s Expanded Access program is currently under development. We will update this page with additional information on this program once it is available. If you have any questions, please contact medinfo@amplyx.com.