Tuesday, May 12, 2020

Florida biotechnology company receives FDA approval to begin clinical trials of EIDD-2801, an antiviral drug showing promise as a treatment for COVID-19

Wendy Holman, CEO of Ridgeback Biotherapeutics

A pharmaceutical company in Miami, Florida, has received FDA approval to begin human testing of an antiviral drug that shows promise as a treatment for COVID-19. Ridgeback Biotherapeutics made the announcement at biospace.com and PR Newswire, in a release dated April 7.

The company describes the drug, EIDD-2801, as "an oral broad-spectrum antiviral proceeding into clinical trials." The drug is similar to remdesivir, a compound developed at UAB that recently became the first FDA-approved treatment for COVID-19. Both drugs are designed to interfere with a coronavirus' ability to copy itself. EIDD-2801, developed at Emory University in Atlanta, is administered in pill form, while remdesivir is received via intravenous therapy. From the biospace.com report:

Ridgeback Biotherapeutics LP, a closely held biotechnology company, and Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University, today announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug application by Drug Innovation Ventures at Emory (DRIVE), LLC, wholly owned by Emory University, for an orally available antiviral compound, EIDD-2801, exclusively licensed to Ridgeback Biotherapeutics, LP (Ridgeback). This action by the FDA allows Ridgeback to initiate human clinical testing of EIDD-2801 in the United States.

"We are thankful to FDA Commissioner Dr. Steven Hahn and his team at the Anti-Viral Division for the unprecedented speed in reviewing our submission, the guidance and the highly collaborative process that ensures this promising drug can advance into the clinical development as fast as possible," said Wendy Holman, Chief Executive Officer of Ridgeback. "We also appreciate the guidance we have received from the Assistant Secretary of Preparedness and Response (ASPR), including discussions that occurred months before COVID-19 first emerged, to help Emory/DRIVE advance the development of EIDD-2801 as quickly as possible to address this global pandemic."

Here are details about how EIDD-2801 is designed to work:

EIDD-2801 prevents the replication of SARS-CoV-2, the virus that causes COVID-19, and has shown potent activity against SARS-CoV and MERS-CoV in animal models of infection. In addition to coronaviruses, EIDD-2801 has broad spectrum activity against a number of diseases of public health concern, including influenza, chikungunya, Ebola, and equine encephalitis (VEE and EEE). The antiviral is orally available and, in addition to COVID-19, is being developed for the treatment of seasonal and pandemic influenza under a contract awarded to Emory Institute for Drug Development by the National Institute of Allergy and Infectious Diseases (NIAID) and for Venezuelan and Eastern equine encephalitis virus (VEEV and EEEV) by the Defense Threat Reduction Agency (DTRA).

"FDA's prompt approval of our IND allows us to initiate human testing for EIDD-2801 as quickly as possible," says George Painter, Ph.D., director of the Emory Institute for Drug Development (EIDD) and CEO of DRIVE. "We are grateful to our collaborators for helping us to assemble this application quickly, and to the FDA for expediting the process. An orally available antiviral medication would be a critical weapon for fighting COVID-19."

Ridgeback and DRIVE have established a partnership to advance EIDD-2801 through clinical development and to optimize availability during the current COVID-19 pandemic. EIDD-2801 was exclusively licensed to Ridgeback in March 2020.

"We look forward to our continued work with the highly experienced drug development team at DRIVE and the dedicated medical, public health and governmental personnel who are on the front line of this pandemic – in the United States and abroad," says Wendy Holman, CEO of Ridgeback Biotherapeutics. "The ability to deliver promising treatments to patients in need is what makes us excited to come to work every day. Ridgeback brings its unique perspective, honed by our success developing an Ebola therapeutic during the 2018-2020 outbreak in the DR Congo, to help advance EIDD-2801 for the treatment of diseases that are critical to pandemics and global health."

Like remdesivir, EIDD-2801 has been around for  a while, showing potential against a number of virus-based illnesses. From the biospace.com report:

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. The development of EIDD-2801 has been funded in part with federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), under contract numbers HHSN272201500008C and 75N93019C00058, and from the Defense Threat Reduction Agency (DTRA), under contract numbers HDTRA1-13-C-0072 and HDTRA1-15-C-0075.

Here is background on Ridgeback Biotherapeutics:

Headquartered in Miami, Florida, Ridgeback Biotherapeutics is a privately held, majority woman-owned biotechnology company focused on orphan and 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. Ridgeback is in the process of completing a Biologics Licensing Application with the Food and Drug Administration for mAb114 (ansuvimab) for the treatment of Ebola. 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 No. 75A50119C00059 and 75A50120C0009.

An article last week at The Daily Report, an Atlanta-based legal newspaper, described intellecutual-property work performed on the EIDD-2801 application and addressed differences between the Emory drug and remdesivir:

Just last week the Food and Drug Administration approved emergency use of Gilead Science’s remdesivir as a treatment for seriously ill hospitalized COVID-19 patients. The drug, which has been tested at Emory and also attacks viruses’ reproduction processes, “was shown to shorten the time to recovery in some patients,” the FDA said.

A key difference between remdesivir and EIDD-2801 is that remdesivir must be administered intravenously, while a drug from EIDD-2801 would be given in a pill—meaning patients could take it at home. “That would allow EIDD-2801 to be taken earlier in the course of the disease, killing off the virus before it wreaks havoc on the body,” according to an article in Chemical and Engineering News (CEN).

From the CEN article:

As the COVID-19 pandemic shut down much of the world, George Painter’s life geared up considerably. In a matter of weeks, Painter and his collaborators have seen the antiviral they were working on—EIDD-2801—go from a promising therapeutic for influenza to a potential weapon in the fight against COVID-19, the disease caused by the novel coronavirus. The drug candidate began a human safety trial in the UK in mid-April, and a US trial is planned for late May.

Painter, a virologist and chemist by training, has devoted his career to working on antivirals, coinventing several approved drugs for HIV and hepatitis B. In 2013, after decades in industry, he joined Drug Innovation Ventures at Emory (DRIVE) as its CEO and became director of the Emory Institute for Drug Development (EIDD). DRIVE and the EIDD aim to move drug candidates from early-stage development and preclinical testing to proof-of-concept clinical trials.

Painter wakes up early every morning to check in on the progress of the EIDD-2801’s clinical trial in the UK, and after a long day’s work of wrangling resources, he heads off to bed hoping that the drug candidate works as well in people as it does in animals. “You just lie awake every night worrying that you’re giving a drug to people, and you want them to be safe,” he says.

Although doctors and scientists are testing a vast arsenal of existing drugs and drug candidates in the fight against the novel coronavirus, SARS-CoV-2, EIDD-2801 stands out. It attacks the same viral enzyme, the RNA-dependent RNA polymerase, as Gilead Sciences’ remdesivir, which the US Food and Drug Administration recently granted emergency use authorization, allowing it to be used by doctors in the pandemic. But unlike remdesivir, which has to be given intravenously, EIDD-2801 can be taken orally as a pill.

This means if EIDD-2801 is shown to be safe and effective, people could take it at home rather than in a hospital. That would allow EIDD-2801 to be taken earlier in the course of the disease, killing off the virus before it wreaks havoc on the body.

EIDD-2801’s other intriguing feature is that it appears to have a high barrier to resistance. Drugs can force viruses to quickly develop mutants that aren’t affected by the drug, which then makes the drug obsolete. But EIDD-2801 hasn’t prompted that sort of resistance in lab tests despite efforts to coerce such mutants to arise.

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