Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

NI 007

Drug Profile

NI 007

Alternative Names: Anti-SARS-CoV-2 neutralising antibody; NI007

Latest Information Update: 06 Apr 2020

At a glance

  • Originator ethris; Neurimmune Therapeutics
  • Class Antivirals; Monoclonal antibodies; RNA
  • Mechanism of Action Immunomodulators
  • 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

  • Research COVID 2019 infections

Most Recent Events

  • 01 Apr 2020 Neurimmune and Ethris agree to co-develop NI 007 for COVID-2019 infections
  • 01 Apr 2020 Early research in COVID-2019 infections in Switzerland (Inhalation)
  • 01 Apr 2020 Neurimmune announces intention to submit regulatory applications for clinical trials of NI 007 for COVID-2019 infections

Development Overview

Introduction

NI 007 is an mRNA-encoded, neutralising anti-SARS-CoV-2 monoclonal antibody, being jointly developed by Neurimmune and Ethris, by using Neurimmune's Reverse Translational Medicine (RTMTM) technology platform, for the treatment of COVID-19 infections. Neutralising antibodies will be translated into therapeutic SNIM®RNA products for inhalation. Early research of an inhalation formulation, is underway in Switzerland.

Neurimmune's RTMTM technology focusses on the cloning of authentic human antibodies from healthy participants, or from patients who recovered from disease, by translating the immune memory of functionally active antibodies into transformative immunotherapeutics. With Ethris' proprietary pulmonary SNIM®RNA technology, the technology can express human SARS-CoV-2 neutralising antibodies directly in the lung to rapidly achieve effective pulmonary antibody concentrations.

Company Agreements

In April 2020, Neurimmune entered into a research and development agreement with Ethris, to develop mRNA-encoded, neutralising anti-SARS-CoV-2 antibodies, administered by inhalation, for the treatment of COVID-19 infections. Under the terms of the agreement, Neurimmune and Ethris will jointly conduct research and development activities while sharing costs and revenues resulting from the collaboration. The companies intend to initiate manufacturing of the drug for planned clinical trials. [1]

Patent Information

Drug Properties & Chemical Synopsis

  • Route of administration Inhalation
  • Formulation unspecified
  • Class Antivirals, Monoclonal antibodies, RNA
  • Mechanism of Action Immunomodulators
  • WHO ATC code

    J05A-X (Other antivirals)

  • EPhMRA code

    J5B9 (Antivirals, others)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Research Switzerland Inhalation / unspecified ethris, Neurimmune Therapeutics 01 Apr 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Neurimmune Therapeutics Originator Switzerland
ethris Originator Germany
Neurimmune Therapeutics Owner Switzerland
ethris Owner Germany

Future Events

Expected Date Event Type Description Updated
31 Dec 2020 Trial Update Neurimmune and Ethris plans a clinical trial for COVID-2019 infections (Inhalation), in the fourth quarter of 2020 (700320499) [1] 13 Apr 2020

Development History

Event Date Update Type Comment
01 Apr 2020 Licensing Status Neurimmune and Ethris agree to co-develop NI 007 for COVID-2019 infections [1] Updated 06 Apr 2020
01 Apr 2020 Phase Change Early research in COVID-2019 infections in Switzerland (Inhalation) [1] Updated 06 Apr 2020
01 Apr 2020 Regulatory Status Neurimmune announces intention to submit regulatory applications for clinical trials of NI 007 for COVID-2019 infections [1] Updated 06 Apr 2020
31 Mar 2020 Trial Update Neurimmune and Ethris plans a clinical trial for COVID-2019 infections (Inhalation), in the fourth quarter of 2020 [1] Updated 13 Apr 2020

References

  1. Neurimmune and Ethris Sign Collaboration Agreement to Rapidly Develop Inhaled mRNA-based Antibody Therapy for the Treatment of COVID-19.

    Media Release
Back to top