Ridgeback Biotherapeutics Announces MHRA Clearance to Begin Human Testing of EIDD-2801 in the UK for COVID-19 and the Start of Phase 1
13 Apr, 2020, 13:44 BST
EIDD-2801, an oral broad-spectrum antiviral, Initiates Clinical Trials
MIAMI, April 13, 2020 /PRNewswire/ -- Ridgeback Biotherapeutics LP, a closely held biotechnology company, announced clearance by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for an orally available antiviral compound, EIDD-2801, to begin human testing. This action by the MHRA allowed Ridgeback to commence Phase 1 in the UK on Friday April 10th.
"We are thankful to the amazing team at MHRA for the careful and expeditious consideration that led to clearance of our application," said Dr. Wayne Holman, Co-Founder of Ridgeback Biotherapeutics. "In this time of great need we were very pleased to collaborate with MHRA and appreciate the advice and guidance we received. As a result, Ridgeback was able to initiate screening at our Phase 1 site in the UK the very next day."
EIDD-2801 is a direct acting anti-viral nucleoside analogue. Essentially, EIDD-2801 tricks RNA viruses into including the wrong building blocks as it tries to reproduce itself. This leads to dramatically reduced levels of virus in animals infected with a wide variety of RNA viruses when treated with EIDD-2801. EIDD-2801 has been shown to treat MERS and SARS (two severe coronavirus infections) in animals when given after an infection has been established. When given prophylactically EIDD-2801 is able to prevent significant manifestations of disease in animals challenged with MERS and SARS.
"We believe if the animal data for severe coronaviruses is replicated in human trials that EIDD-2801 has the potential to safely treat COVID-19 with a short oral course of therapy that reduces the severity of disease and hopefully prevents the need for hospitalization and the need for ventilator support. We are grateful to our partners at DRIVE and to our scientific collaborators at UNC and Vanderbilt for all of the work it took to bring this project from an idea to patients. An orally available antiviral medication has the ability to change the course of this pandemic," said Wendy Holman, Co-founder and CEO of Ridgeback Biotherapeutics.
Ridgeback and DRIVE signed a partnership agreement in March 2020 with the focused mission of advancing EIDD-2801 through clinical development and to optimizing availability during the current COVID-19 pandemic.
"We are focused not only on the clinical development but also ramping up commercial supply at risk in advance of what we hope will be future positive clinical data," says Wendy Holman, CEO of Ridgeback Biotherapeutics. "Ridgeback has a history of pursuing manufacturing at risk in advance of positive clinical data. Our experience gives us a unique perspective on what types of partnerships are necessary in order to advance programs as efficiently as possible. We are thrilled that our partners at DRIVE share our same vision. The teams at Ridgeback and DRIVE have been working around the clock, 7 days a week in order to advance this program. I am so thankful to our employees and partners for their tireless efforts to advance the EIDD-2801 program."
About EIDD-2801:
EIDD-2801 is an orally bioavailable form of a highly potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. In animal studies of two distinct coronaviruses (SARS-CoV1 and MERS), EIDD-2801 has been shown to improve pulmonary function, decrease body weight loss and reduce the amount of virus in the lung. In addition to activity against coronaviruses, EIDD-2801, in laboratory studies, has demonstrated activity against seasonal and bird influenza, respiratory syncytial virus, chikungunya virus, Ebola virus, Venezuelan equine encephalitis virus, and Eastern equine encephalitis virus.
About Ridgeback Biotherapeutics LP:
Headquartered in Miami, Florida, Ridgeback Biotherapeutics is a privately held, majority woman-owned biotechnology company focused on orphan and emerging infectious diseases. Initial funding for Ridgeback Biotherapeutics originated from Wayne and Wendy Holman; two individuals committed to investing in and supporting technologies that will make the world a better place. The team at Ridgeback is dedicated to working toward finding life-saving and life-changing solutions for patients and diseases that need champions.
About DRIVE:
DRIVE is a non-profit LLC wholly owned by Emory University and started as an innovative approach to drug development. Operating like an early stage biotechnology company, DRIVE applies focus and industry development expertise to efficiently translate discoveries to address viruses of global concern. DRIVE's mission is to discover and develop antiviral drugs for emerging infections, pandemic threats, and biodefense (e.g. COVID-19, swine flu, bird flu, dengue, chikungunya, Ebola, Zika, and viral encephalitis). Because these diseases are major threats, antiviral drugs are critically needed to treat them; however, they are generally not profitable enough for industry to pursue, and thus are considered neglected diseases. DRIVE is unique in that it brings industry expertise to the assets of a leading research University to develop potential antiviral drugs to a de-risked value inflection point that substantially increases the probability of the potential drug being licensed by industry and developed for the ultimate benefit of the public. DRIVE's executive team, led by George Painter, has over three decades of drug development experience within both large pharmaceutical and biotechnology companies, including leading the development of multiple FDA approved antivirals to treat HIV and Influenza, among other viral diseases, including AZT and Relenza.
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