ENU 200
Alternative Names: ENU200Latest Information Update: 28 Sep 2020
At a glance
- Originator Catholic University of Murcia; Ennaid Therapeutics
- Developer Ennaid Therapeutics
- Class Antivirals; Small molecules
- Mechanism of Action Glycoprotein inhibitors; Peptide hydrolase inhibitors
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Preclinical COVID 2019 infections
Most Recent Events
- 02 Apr 2020 Ennaid Therapeutics has patent pending for ENU 200
- 02 Apr 2020 Ennaid Therapeutics plans to launch ENU 200 in COVID-2019 infections (PO) by end-2020
- 02 Apr 2020 Ennaid Therapeutics plans an in-home phase III trial in COVID-2019 infections (using the company's iClickCare® secure clinical reporting software service) (PO) after discussion with US FDA and other regulatory agencies
Development Overview
Introduction
ENU 200 is being developed as a repurposed, orally deliverable antiviral drug by Ennaid Therapeutics, for the treatment of asymptomatic, mild to moderate COVID-2019 infections. The patent-pending drug, which was earlier approved against other indications, displays antiviral activity against two SARS-CoV-2 proteins, S glycoprotein and Mpro. S glycoprotein of covid virus is a class I viral fusion protein situated on the outer envelope of the virion, which facilitates host cell attachment by recognition of host cell receptors, along with a mediation of host cell membrane and viral membrane fusion during infection. Ennaid's in silico platform proposes that ENU 200 matches the receptor binding domain (RDB) by simultaneously blocking the key residues for binding to ACE2, (Gln493 and Asn501). ENU 200 also blocks CoV main protease (Mpro), which is responsible for CoV replication, and also for conversion of the polypeptide into functional proteins. Data has revealed Mpros as being largely conserved structures. This simultaneous dual blockage, the company believes, will pave the way for expanding treatment landscape for COVID-2019 and other coronaviruses, on account of an enhanced antiviral activity. In vitro and in vivo studies have validated that ENU 200 inhibits viral protease in a different viral infection, and has a good safety profile. Preclinical development is underway in the US.
Ennaid Therapeutics intends to utilise the US FDA's emergency/compassionate use regulatory pathway, or 505(b)(2) application process for ENU 200 as well an approval for compassionate use in India [1] [2] .
Company Agreements
In June 2021, Strides Pharma Science Limited entered into an exclusive partnership with Ennaid Therapeutics, to produce an oral, repurposed medication to treat mild, moderate and asymptomatic cases of COVID‐19. [1]
Key Development Milestones
In Preclinical studies, initial tests showed that ENU 200 had antiviral activity effective against SARS CoV‐2, the virus that causes COVID‐19, by inhibiting 90% of the virus' replication in vitro studies [1] .
Patent Information
In April 2020, Ennaid Therapeutics reported that it has patent pending for ENU 200 [2] .
Drug Properties & Chemical Synopsis
- Route of administration PO
- Formulation unspecified
- Class Antivirals, Small molecules
- Target Glycoprotein; Peptide hydrolase
- Mechanism of Action Glycoprotein inhibitors; Peptide hydrolase inhibitors
-
WHO ATC code
J05A-X (Other antivirals)
-
EPhMRA code
J5B (Antivirals, excluding anti-HIV products)
Table of Contents
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | - | Preclinical | USA | PO / unspecified | Ennaid Therapeutics | 02 Apr 2020 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Catholic University of Murcia | Originator | Spain |
| Ennaid Therapeutics | Originator | USA |
| Ennaid Therapeutics | Owner | USA |
| Catholic University of Murcia | Owner | Spain |
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2020 | Regulatory Status | Ennaid Therapeutics plans to launch ENU 200 in COVID-2019 infections (PO) by end-2020 [2] | 08 Apr 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 02 Apr 2020 | Regulatory Status | Ennaid Therapeutics intends to utilise the US FDA's emergency/compassionate use regulatory pathway, or 505(b) application process, as well an approval for compassionate use in India for ENU 00 (989174) (937604) Updated 28 Sep 2020 |
| 02 Apr 2020 | Patent Information | Ennaid Therapeutics has patent pending for ENU 200 [2] Updated 08 Apr 2020 |
| 02 Apr 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in USA (PO) before April 2020 [2] Updated 08 Apr 2020 |
| 02 Apr 2020 | Regulatory Status | Ennaid Therapeutics plans to launch ENU 200 in COVID-2019 infections (PO) by end-2020 [2] Updated 08 Apr 2020 |
| 02 Apr 2020 | Trial Update | Ennaid Therapeutics plans an in-home phase III trial in COVID-2019 infections (using the company's iClickCare® secure clinical reporting software service) (PO) after discussion with US FDA and other regulatory agencies [2] Updated 08 Apr 2020 |
References
-
ENNAID THERAPEUTICS PARTNERS EXCLUSIVELY WITH STRIDES TO MANUFACTURE LIFE-SAVING ORAL COVID-19 TABLET.
Media Release -
Ennaid Therapeutics Announces Development of ENU200, A New Antiviral Therapeutic for the Treatment of COVID-19.
Media Release
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