- FIRST DOSE OF EVT894, A MONOCLONAL ANTIBODY AGAINST CHIKUNGUNYA VIRUS ADMINISTERED TO A HEALTHY PARTICIPANT IN A PHASE I STUDY
- DEVELOPMENT OF EVT894 BY EVOTEC TOGETHER WITH ITS PARTNERS NIAID AND DUKE CLINICAL RESEARCH INSTITUTE
- ADDRESSING UNMET MEDICAL NEEDS IN GLOBAL HEALTH
Hamburg, Germany, 28 January 2021:
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced that EVT894, a monoclonal antibody to treat and potentially prevent chikungunya virus infections, has entered clinical development.
The Phase I, randomized, double-blind, single-center, 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 program 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 characterized 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, the 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 neutralizing 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 neutralizing antibody that was derived from a chikungunya virus-infected patient, we believe it holds great promise to 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
Chikungunya is a mosquito-borne viral disease that causes fever and severe joint and muscle pain as well as headaches, nausea, fatigue, and rashes. Joint pain is often debilitating and can persist for months to years. Currently, there is no targeted therapy for the disease, and treatment is focused on relieving the symptoms. As the disease is mosquito-borne, it typically occurs in seasonal outbreaks in tropical regions, therefore yearly figures may differ significantly. In 2017, more than 1 million cases were reported in the Americas and Caribbean islands, and over the past decades, the disease has spread to other, non-tropical regions as well.
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 that might also work as a prophylactic solution for the 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.
ABOUT EVOTEC SE
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups, and venture capitalists. We operate worldwide and our more than 3,500 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry’s need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases, and women’s health. On this basis, Evotec has built a broad and deep pipeline of more than 100 co-owned product opportunities at clinical, pre-clinical, and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB, and others. For additional information please go to www.evotec.com and follow us on Twitter @Evotec.