DGAP-News: Evotec SE
/ Key word(s): Miscellaneous
28.01.2021 / 07:30
The issuer is solely responsible for the content of this announcement.
Hamburg, Germany, 28 January 2021:
The Phase I, randomised, double-blind, single centre, single dose escalation study to evaluate the safety, pharmacokinetics, and immunogenicity of EVT894 vs placebo in healthy volunteers (five dose-cohorts of 8 subjects) is sponsored and funded by the National Institute of Allergy and Infectious Diseases (“NIAID”), part of the National Institutes of Health with funds from a Phase I Clinical Trial Units for Therapeutics programme award (Contract No. HHSN272201500006I) and is being conducted at Duke Clinical Research Institute (“DCRI”), at Duke University School of Medicine in Durham, North Carolina, USA.
Chikungunya virus is a mosquito-borne alphavirus that poses a significant threat to public health in tropical and subtropical regions. Chikungunya disease is characterised by debilitating musculoskeletal pain that can persist for months to years. Although mortality is not high, the public health burden is significant: 1.3 billion people live in areas endemic for chikungunya and it is prevalent in approximately 60 countries across the world, typically occurring in seasonal outbreaks. In recent years, chikungunya virus reached new areas including non-tropical regions. There are currently no effective therapies or approved vaccines to treat or prevent chikungunya infection or disease.
EVT894 is a fully human monoclonal antibody that targets a viral protein and has shown potent neutralising activity in in vitro and in vivo models. The antibody was originally identified by Prof. James E. Crowe, and others at Vanderbilt University Medical Center, in Nashville, Tennessee (supported by NIH government grants: K08 AI103038, F32 AI096833, and U54 AI057157, awarded by the National Institutes of Health).
The monoclonal antibody was initially developed by Sanofi and was among the projects out-licensed to Evotec as part of the transfer of Sanofi’s Lyon-based infectious disease R&D unit to Evotec in July 2018. Thanks to its exclusive rights on EVT894, and with support from the Defense Advanced Research Projects Agency of the US Department of Defense and from NIAID, Evotec was able to pursue pre-clinical development to identify an investigational product with both therapeutic and prophylactic potential that has now entered Phase I. At a certain point during the clinical development process, Evotec will take over manufacturing of EVT894 at its biologics subsidiary Just – Evotec Biologics in Seattle, USA.
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, said: “Chikungunya virus infections are on the rise in many regions in the world. As EVT894 is a neutralising antibody that was derived from a chikungunya virus-infected patient, we believe it holds great promise to be become an effective therapeutic and prophylactic treatment option and is thus expected to make a real difference for people affected by the disease.”
About Chikungunya and EVT894
EVT894 is a first-in-class anti-viral therapeutic agent against chikungunya. The programme was initially developed by Sanofi as SAR440894. The Phase I study is registered on Clinicaltrials.gov under the identifier NCT04441905. EVT894 is a fully human monoclonal antibody which might also work as a prophylactic solution for immediate protection of people at risk during chikungunya outbreaks. Evotec is also developing a rapid, affordable and robust point-of-care chikungunya test that could serve as a companion diagnostic or stand-alone test for the virus.
Evotec acknowledges the support of the Defense Advanced Research Projects Agency (“DARPA”) and NIAID, as well as several non-governmental and academic partners in advancing this project towards clinical testing.
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