Atriva Therapeutics GmbH has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of hantavirus infections. These RNA viruses may lead to serious diseases in humans with a high risk of fatality and have been classified by the CDC as a potential bioterrorism agent. Atriva specifically develops first-in-class, host-targeting small molecules that aim to inhibit viral replication and to favorably modulate the body’s immune response to treat severe respiratory diseases induced by RNA viruses.
“Hantavirus infections and the resulting diseases, Hantavirus Pulmonary Syndrome and Hemorrhagic Fever with Renal Syndrome, are potentially life-threatening conditions with no specific treatment to date,” said Prof. Dr. Oliver Planz, CSO of Atriva Therapeutics. “Antiviral efficacy of zapnometinib against hantavirus has been previously proven in vitro in an academic collaboration. With its antiviral, immunomodulating properties as well as its positive safety and tolerability profile, which has been demonstrated already in a Phase I trial, zapnometinib shows the potential to become the first oral drug to specifically treat hantavirus infections.”
Dr. Rainer Lichtenberger, CEO of Atriva Therapeutics, commented: “The Orphan Drug Designation we received for our lead drug candidate zapnometinib is an important milestone towards addressing the urgent needs of patients infected with hantavirus. We are very pleased about this external validation from the FDA and we are looking forward to advancing zapnometinib towards full development in this indication, which is considered an emerging global health threat due to man-made environmental and climatic changes. I am very proud of the excellent scientific research that has yielded convincing results enabling us to progress zapnometinib into this new indication, alongside influenza and COVID-19.”
In humans, hantaviruses, which are usually transmitted by rodents, can cause two different types of severe diseases. Hantavirus Pulmonary Syndrome (HPS) is mainly prevalent throughout the Americas while Hemorrhagic Fever with Renal Syndrome (HFRS) is predominant in Asia and Europe. Both conditions can cause severe lung problems, hemorrhagic fever and death, with fatality rates between 35% and 50% for HPS and between 1% and up to 15% for HFRS, respectively.
Hantaviruses affect around 30,000 people annually and are emerging as a global health threat, due to environmental changes and ecological alterations that are associated with changing rodent populations and their habitats. As of 2019, 816 laboratory-confirmed cases of hantavirus disease have been reported in the U.S. since the start of surveillance in 1993. ECDC reports more than 4,000 annual cases of HFRS for Europe, and 1,534 for Germany alone in 2019, whereas annual numbers of HFRS cases are expected to be as high as 150,000, with more than 50% occurring in China.
To date, neither treatments nor vaccines against HPS or HFRS have yet been made available on a global scale. Therefore, hantavirus infections cause a high unmet medical need. The CDC classifies hantaviruses as Category C bioterrorism pathogens that could be engineered for mass dissemination in the future because of its availability; ease of production and dissemination; and potential for high morbidity and mortality rates, as well as a major health impact.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!