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EIDD 2801

Drug Profile

EIDD 2801

Alternative Names: EIDD-2801

Latest Information Update: 02 Jun 2020

At a glance

  • Originator Emory University
  • Developer Emory University; Ridgeback Biotherapeutics
  • Class Antivirals; Esters; Ribonucleosides; Small molecules
  • Mechanism of Action Virus replication inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I COVID 2019 infections
  • Preclinical Chikungunya virus infections; Eastern equine encephalomyelitis; Ebola virus infections; Influenza virus infections; Middle East respiratory syndrome coronavirus; Respiratory syncytial virus infections; Severe acute respiratory syndrome; Venezuelan equine encephalomyelitis

Most Recent Events

  • 02 Jun 2020 Ridgeback Biotherapeutics plans a phase II trial for Severe acute respiratory syndrome (in patients with COVID-2019 infections) in USA, in May 2020 (NCT04405570)
  • 28 May 2020 Ridgeback Biotherapeutics plans a phase II trial for COVID-19 infections in May 2020 (PO, Capsule) (NCT04405739)
  • 27 May 2020 Ridgeback Bio signs agreement with Merck to develop and commercialise EIDD 2801

Development Overview

Introduction

EIDD 2801 is an orally bioavailable, isopropylester prodrug of the ribonucleoside analog N 4-hydroxycytidine (NHC, EIDD 1931) that inhibits the replication of multiple RNA viruses, being developed by Ridgeback Biotherapeutics under a license from Drug Innovations at Emory (DRIVE, a wholly owned subsidiary of Emory University) for the prevention of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) coronavirus and treatment of COVID-2019 infections caused due to SARS-CoV-2, severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) coronavirus, influenza, chikungunya, syncytial virus, Ebola virus infections, Eastern equine encephalitis viruses, and venezuelan equine encephalitis virus. EIDD 2801 acts by tricking the RNA viruses to include the wrong building blocks as it tries to reproduce itself. Clinical development for COVID- 2019 infections is ongoing in the UK. Preclinical development is underway for other indications in the US.

Company Agreements

In May 2020, Ridgeback Biotherapeutics signed an agreement with Merck for the development of EIDD 2801. Under the terms of agreement, Merck, through a subsidiary, will acquired exclusive worldwide rights to develop and commercialise EIDD 2801 and related molecules. Merck will be responsible for clinical development, regulatory filings and manufacturing. The transaction is subject to the expiration or earlier termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and other customary closing conditions. [1]

In March 2020, Ridgeback Biotherapeutics entered into a licensing agreement with Drug Innovations at Emory (DRIVE, a wholly owned subsidiary of Emory University) for the development of EIDD 2801. Under the terms of the agreement, Ridgeback Biotherapeutics will be responsible for advancing the drug through clinical development and ensuring that EIDD 2801 is available during the COVID-19 pandemic. Ridgeback Biotherapeutics will also be responsible for conducting the necessary trials to bring EIDD 2801 to licensure. Financial terms of the agreement were not disclosed [2]

Key Development Milestones

In April 2020, Ridgeback Biotherapeutics initiated a phase I trial to evaluate EIDD 2801 for the treatment of COVID-2019 infections in the UK. The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the clinical trial application and granted permission to initiate clinical testing in the same month [3] . In May 2020, Ridgeback Biotherapeutics released safety data for the trial [1] .

In April 2020, Ridgeback Biotherapeutics announced today that the US FDA approved an IND application of EIDD 2801 to initiate the clinical trial for the treatment of COVID-2019 infections in the US [4] .

EIDD 2801 demonstrated potent activity against seasonal and bird influenza, respiratory syncytial virus, chikungunya virus, Ebola virus, Venezuelan equine encephalitis virus, and Eastern equine encephalitis virus in laboratory studies. In April 2020, pharmacodynamics data from preclinical studies of two distinct coronaviruses (SARS-CoV1 and MERS) were released by Ridgeback Biotherapeutics [3] .

In preclinical studies, EIDD 2801 prevented the replication of SARS-CoV-2 virus that cause COVID-2019 infections and also showed potent activity against severe acute respiratory syndrome (SARS) and middle east respiratory syndrome (MERS) in animal model of infection [4] .

In October 2019, results from preclinical studies in influenza were released by Emory University [5] .

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation unspecified
  • Class Antivirals, Esters, Ribonucleosides, Small molecules
  • Target Virus replication
  • Mechanism of Action Virus replication inhibitors
  • WHO ATC code

    J05A-X (Other antivirals)

  • EPhMRA code

    J5B9 (Antivirals, others)

  • Molecular formula C13 H19 N3 O7
  • CAS Registry Number 2349386-89-4

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Phase I United Kingdom PO / unspecified Ridgeback Biotherapeutics 10 Apr 2020
COVID 2019 infections - - Preclinical USA PO / unspecified Emory University, Ridgeback Biotherapeutics 19 Mar 2020
Chikungunya virus infections - - Preclinical USA PO / unspecified Emory University 19 Mar 2020
Eastern equine encephalomyelitis - - Preclinical USA PO / unspecified Emory University 19 Mar 2020
Ebola virus infections - - Preclinical USA PO / unspecified Ridgeback Biotherapeutics 15 Apr 2020
Influenza virus infections - - Preclinical USA PO / unspecified Emory University, Ridgeback Biotherapeutics 19 Mar 2020
Middle East respiratory syndrome coronavirus - - Preclinical USA PO / unspecified Emory University 19 Mar 2020
Middle East respiratory syndrome coronavirus - Prevention Preclinical USA PO / unspecified Ridgeback Biotherapeutics 13 Apr 2020
Respiratory syncytial virus infections - - Preclinical USA PO / unspecified Emory University 19 Mar 2020
Severe acute respiratory syndrome - - Preclinical USA PO / unspecified Emory University 17 Mar 2020
Severe acute respiratory syndrome - Prevention Preclinical USA PO / unspecified Ridgeback Biotherapeutics 13 Apr 2020
Venezuelan equine encephalomyelitis - - Preclinical USA PO / unspecified Emory University 19 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Emory University Originator USA
Emory University Owner USA
Ridgeback Biotherapeutics Licensee USA
Merck & Co Sub-licensee World
National Institute of Allergy and Infectious Diseases Funder USA

Scientific Summary

Adverse Events

Phase I:

In a phase I trial, treatment with EIDD-2801 was well tolerated in patients with COVID-2019 infection [1] [6] .

Pharmacodynamics

In preclinical studies, oral administration of EIDD 2801 resulted in decreased group pandemic 1 and group 2 seasonal influenza A shed virus load by multiple orders of magnitude and alleviated fever, airway epithelium histopathology, and inflammation. In disease-relevant well-differentiated human air-liquid interface airway epithelia, inhibitory concentrations were low nanomolar against influenza A and B viruses. A therapeutic window >1713 was observed and dosing parameters required for efficacious human therapy was established when antiviral efficacy and cytotoxicity thresholds with pharmacokinetic profiles in human airway epithelium models were correlated [5] .

In animal models infected with Severe acute respiratory syndrome (SARS)/ Middle East respiratory syndrome coronavirus (MERS) treatment with EIDD 2801 led to therapeutic benefits. In models with (SARS-CoV1 and MERS), EIDD 2801 improved pulmonary function, decreased body weight loss and reduced the amount of virus in the lung. The candidate also prevented significant manifestations of disease following prophylactic administration in animals challenged with MERS and SARS [3] .

Future Events

Expected Date Event Type Description Updated
30 Jun 2020 Trial Update Ridgeback Biotherapeutics plans clinical trials for COVID-2019 infections and Influenza virus infections in Q2 2020 [2] 15 Apr 2020

Development History

Event Date Update Type Comment
02 Jun 2020 Trial Update Ridgeback Biotherapeutics plans a phase II trial for Severe acute respiratory syndrome (in patients with COVID-2019 infections) in USA, in May 2020 (NCT04405570) Updated 02 Jun 2020
28 May 2020 Trial Update Ridgeback Biotherapeutics plans a phase II trial for COVID-19 infections in May 2020 (PO, Capsule) (NCT04405739) Updated 01 Jun 2020
27 May 2020 Licensing Status Ridgeback Bio signs agreement with Merck to develop and commercialise EIDD 2801 [1] Updated 01 Jun 2020
27 May 2020 Scientific Update Adverse events data from a phase I trial in COVID-2019 infection released by Ridgeback Biotherapeutics [1] Updated 01 Jun 2020
15 Apr 2020 Phase Change - Preclinical Preclinical trials in Ebola virus infections in USA (PO) before April 2020 [3] Updated 15 Apr 2020
13 Apr 2020 Phase Change - Preclinical Preclinical trials in Middle East respiratory syndrome coronavirus (Prevention) in USA (PO) before April 2020 [3] Updated 15 Apr 2020
13 Apr 2020 Phase Change - Preclinical Preclinical trials in Severe acute respiratory syndrome (Prevention) in USA (PO) before April 2020 [3] Updated 15 Apr 2020
13 Apr 2020 Scientific Update Pharmacodynamics data from preclinical studies in Severe acute respiratory syndrome and Middle east respiratory syndrome coronavirus released by Ridgeback Biotherapeutics [3] Updated 15 Apr 2020
10 Apr 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections in United Kingdom (PO) [3] Updated 15 Apr 2020
09 Apr 2020 Regulatory Status The UK Medicines and Healthcare products Regulatory Agency (MHRA) approves clinical trial application for EIDD 2801 in COVID-2019 infections [3] Updated 15 Apr 2020
06 Apr 2020 Regulatory Status The US FDA approves IND application for EIDD 2801 to commence the clinical trial for COVID-2019 infections [4] Updated 08 Apr 2020
19 Mar 2020 Trial Update Ridgeback Biotherapeutics plans clinical trials for COVID-2019 infections and Influenza virus infections in Q2 2020 [2] Updated 15 Apr 2020
19 Mar 2020 Licensing Status Ridgeback Biotherapeutics in-licenses EIDD 2801 from Emory University Updated 01 Apr 2020
19 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in USA (PO) before March 2020 [2] Updated 01 Apr 2020
23 Oct 2019 Phase Change - Preclinical Preclinical trials in Chikungunya virus infections in USA (PO) before October 2019 [2] [5] Updated 01 Apr 2020
23 Oct 2019 Phase Change - Preclinical Preclinical trials in Eastern equine encephalomyelitis in USA (PO) before October 2019 [2] Updated 01 Apr 2020
23 Oct 2019 Phase Change - Preclinical Preclinical trials in Influenza virus infections in USA (PO) before October 2019 [2] [5] Updated 01 Apr 2020
23 Oct 2019 Phase Change - Preclinical Preclinical trials in Middle East respiratory syndrome coronavirus in USA (PO) before October 2019 [2] [5] Updated 01 Apr 2020
23 Oct 2019 Phase Change - Preclinical Preclinical trials in Respiratory syncytial virus infections in USA (PO) before October 2019 [2] Updated 01 Apr 2020
23 Oct 2019 Phase Change - Preclinical Preclinical trials in Severe acute respiratory syndrome in USA (PO) before October 2019 [2] [5] Updated 01 Apr 2020
23 Oct 2019 Phase Change - Preclinical Preclinical trials in Venezuelan equine encephalomyelitis in USA (PO) before October 2019 [2] [5] Updated 01 Apr 2020
23 Oct 2019 Scientific Update Pharmacodynamics data from preclinical studies in Influenza virus infections released by Emory University [5] Updated 01 Apr 2020

References

  1. Merck and Ridgeback Bio Collaborate to Advance Development of Novel Antiviral Candidate, EIDD-2801.

    Media Release
  2. Ridgeback Biotherapeutics and Drug Innovations Ventures at Emory Partner to Develop Clinical Stage Coronavirus Treatment.

    Media Release
  3. Ridgeback Biotherapeutics Announces MHRA Clearance to Begin Human Testing of EIDD-2801 in the UK for COVID-19 and the Start of Phase 1.

    Media Release
  4. FDA Clears the Way for Ridgeback Biotherapeutics to begin Human Testing of a Promising Potential Treatment for COVID-19.

    Media Release
  5. Characterization of orally efficacious influenza drug with high resistance barrier in ferrets and human airway epithelia. Internet-Doc 2020;.

    Available from: URL: https://www.ncbi.nlm.nih.gov/pubmed/31645453
  6. A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of EIDD-2801 Following Oral Administration to Healthy Volunteers

    ctiprofile
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