Two Randomized Double-Blind Placebo Controlled Studies In COVID-19 Patients Follow Phase 1 Trials Showing Safety & Promising Exposures in Humans
MIAMI–(BUSINESS WIRE)–Ridgeback Biotherapeutics announces the launch of two Phase 2 clinical trials to test the efficacy of EIDD-2801 as an anti-viral treatment for COVID-19. Phase 1 trials recently determined that EIDD-2801 is safe in human doses that provide blood levels well above levels that animal models suggest should be effective against SARS-CoV-2, the virus which causes COVID-19. EIDD-2801 will be administered to patients 18 years old and over in two studies: Study 2003 will enroll recently symptomatic, newly diagnosed patients in a home, or out of hospital, setting; Study 2004 will enroll hospitalized patients with COVID-19.
To ensure that EIDD-2801 is rapidly available for patients if the medicine proves to be an effective treatment for COVID-19, Ridgeback has been manufacturing hundreds of thousands of doses at its own risk and expense — with plans for the company to produce as many as a million treatment courses by the fall even in advance of definitive clinical data.
“While it is unclear if EIDD-2801 will have the intended efficacy that the Ridgeback team believes is possible, it is imperative to provide immediate and ample supply to the world should the clinical trials be successful,” said Wendy Holman, co-founder and CEO of Ridgeback Biopharmaceuticals. “Phase 1 is the riskiest phase of drug development. Since the start of the pandemic the dedicated team at Ridgeback has worked 16 hour days, 7 days a week to demonstrate that EIDD-2801 could achieve potentially therapeutic blood levels in humans with doses that were well tolerated.”
“We are pleased to have safely moved from preclinical to efficacy trials in COVID-19 patients in just two months,” said Dr. Wayne Holman, co-founder and scientific advisor of Ridgeback Biotherapeutics. “The goal of these studies is to explore the ability of EIDD-2801 to rapidly eliminate the SARS-CoV2 virus. If EIDD-2801 is able to eliminate the virus much more quickly than placebo we believe that will be the first indicator that EIDD-2801 could possibly change the course of disease in individual patients, halt the disease in the early stages, potentially reduce the time during which patients are infectious to others and change the course of the pandemic.”
EIDD-2801 is an oral nucleoside analogue that has demonstrated extraordinarily favorable tolerability in Phase 1 at all doses tested. Blood levels at and above those associated with potent anti-viral activity in animal models and the 3D Human Airway Epithelial model have been achieved in participants in the Phase 1 study. Both Phase 2 studies will follow intensive virology including PCR and viral culture as well as clinical outcomes. This will be the first test of EIDD-2801’s anti-viral activity in humans.
When Ridgeback licensed the program in March the company’s partners had contracts in place to fund a phase 1 study late this year evaluating EIDD-2801’s potential as an influenza treatment.
Ridgeback then filed an IND and a CTA for COVID-19 and self-funded all of Ridgeback’s phase 1 activities in order to accelerate development and, hopefully, clinical use.
Ridgeback plans to initiate large multi thousand patient confirmatory studies for EIDD-2801 in COVID-19 patients beginning in July.
About Study 2004
Newly hospitalized COVID-19 patients who are 18 years and older with a positive PCR by nasopharyngeal swab will be randomized to one of 2 doses of EIDD-2801 or placebo. Patients will receive 2 daily oral doses for 5 days. Multiple oral and upper airway samples will be followed for reduction in viral load and viral status and patients will be followed for clinical endpoints. The primary objectives of the study are improvement in time to negativity on PCR as well as safety. Secondary endpoints include time to discharge, improvement in symptoms, use of mechanical ventilation and survival. Patients will also be followed for time to viral negativity by viral culture. Additional information about this trial can be found on www.clinicaltrials.gov.
About Study 2003
Newly diagnosed non hospitalized COVID-19 patients who are 18 years and older with a positive PCR by nasopharyngeal swab will be randomized to EIDD-2801 or placebo. Patients will receive 2 daily oral doses for 5 days. Multiple oral and upper airway samples will be followed for reduction in viral load and viral status and patients will be followed for clinical endpoints. The primary objectives of the study are improvement in time to negativity on PCR and safety. Secondary endpoints include time to discharge, improvement in symptoms, use of mechanical ventilation and survival. Patients will also be followed for time to viral negativity by viral culture. Additional information about this trial can be found on www.clinicaltrials.gov.
EIDD-2801 is an investigational, orally-bioavailable form of a 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-CoV-1 and MERS), EIDD-2801 has been shown to improve pulmonary function, decrease body-weight loss and reduce the amount of virus in the lung. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. Since licensed by Ridgeback all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman.
About Ridgeback Biopharmaceuticals
Ridgeback Biopharmaceuticals was co-founded by CEO Wendy Holman and Dr. Wayne Holman, a scientific advisor to the company, with a focus on developing anti-viral medications for diseases that have epidemic and pandemic risk. Ridgeback Biotherapeutics is a majority woman-owned biotechnology company which is dedicated to finding life-saving and life-changing solutions for patients and diseases that need champions. 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. Ridgeback is in the process of completing a Biologics Licensing Application with the Food & Drug Administration for mAb114 (ansuvimab) for the treatment of Ebola, which received Breakthrough Therapy Designation in September 2019. Ansuvimab development has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract Numbers 75A50119C00059 and 75A50120C0009.
John Eddy: [email protected], (646) 660-8648