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ASC 09/ritonavir - Ascletis Pharmaceuticals

Drug Profile

ASC 09/ritonavir - Ascletis Pharmaceuticals

Alternative Names: ASC 09F; ASC-09/ritonavir; Ritonavir/ASC-09

Latest Information Update: 16 Apr 2020

At a glance

  • Originator Ascletis
  • Developer Ascletis; The First Affiliated Hospital of Zhejiang University School of Medicine; The Second Affiliated Hospital of Chongqing Medical University
  • Class Amides; Antiretrovirals; Carbamates; Small molecules; Thiazoles
  • Mechanism of Action Cytochrome P 450 enzyme system inhibitors; HIV protease 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
  • Available For Licensing Yes

Highest Development Phases

  • Phase II COVID 2019 infections; HIV infections

Most Recent Events

  • 13 Apr 2020 Phase-II clinical trials in HIV infections in China (PO)
  • 13 Apr 2020 National Medical Products Administration (NMPA) approves IND application for ASC0 9F in COVID-19 infections
  • 17 Feb 2020 ASC 09/ritonavir is available for licensing as of 17 Feb 2020. http://ascletis.com.cn/single3/136.html

Development Overview

Introduction

An orally administered, fixed dose combination of ASC 09 [see Adis Insight Drug profile800031712] and ritonavir [see Adis Insight Drug profile800004117] is being developed by Ascletis Pharmaceuticals for the treatment of COVID-2019 infections (pneumonia) and HIV infections. ASC 09 is a protease inhibitor that is reported to have high antiviral potency and a high genetic barrier to resistance. Ritonavir is a small molecule of CYP3A4 inhibitor. Clinical development is ongoing in China.

As of February 2020, Ascletis Pharmaceuticals is looking for partners for development of ASC 09/ritonavir (Ascletis Pharmaceuticals website, February 2020).

Key Development Milestones

In April 2020, Ascletis Pharma received IND approval from National Medical Products Administration (NMPA) for ASC0 9F (ASC09/ritonavir ifxed-dose combination) [1]

As of April 2020, phase II development of ASC0 9F was underway for treatment of HIV infections [1] (Ascletis Pharma pipeline, April 2020)

In February 2020, The Second Affiliated Hospital of Chongqing Medical University initiated phase II trial to evaluate safety and efficacy of ASC09/ritonavir tablets, lopinavir/ ritonavir (Kaletra) and umifenovir (Arbidol) tablets in combination with interferon aerosol in the treatment of COVID-2019 infections (ChiCTR2000029759). The randomised trial intends to enrol approximately 60 patients in China [2] .

In February 2020, The First Affiliated Hospital of Zhejiang University School of Medicine initiated an early phase I trial to compare the safety and efficacy of ASC 09/ritonavir and lopinavir/ritonavirin patients with COVID-2019 infections (ChiCTR2000029603). The randomised trial intends to enrol approximately 80 patients in China.

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation Tablet
  • Class Amides, Antiretrovirals, Carbamates, Small molecules, Thiazoles
  • Target Cytochrome P 450 enzyme system; HIV protease
  • Mechanism of Action Cytochrome P 450 enzyme system inhibitors; HIV protease inhibitors
  • WHO ATC code

    J05A (Direct acting antivirals)

    J05A-E (Protease inhibitors)

    J05A-E03 (Ritonavir)

  • EPhMRA code

    J5C (HIV antivirals)

    J5C2 (Protease inhibitors)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections With Interferon aerosol Combination therapy Phase II China PO / Tablet The Second Affiliated Hospital of Chongqing Medical University 15 Feb 2020
COVID 2019 infections coronavirus pneumonia In adults, In the elderly Phase I China PO / Tablet The First Affiliated Hospital of Zhejiang University School of Medicine 06 Feb 2020
HIV infections - - Phase II China PO / Tablet Ascletis 13 Apr 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Ascletis Originator China
Ascletis Owner China
The First Affiliated Hospital of Zhejiang University School of Medicine Collaborator China
The Second Affiliated Hospital of Chongqing Medical University Collaborator China

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
Ascletis - Unspecified - 17 Feb 2020

Development History

Event Date Update Type Comment
13 Apr 2020 Phase Change - II Phase-II clinical trials in HIV infections in China (PO) [1] Updated 16 Apr 2020
13 Apr 2020 Regulatory Status National Medical Products Administration (NMPA) approves IND application for ASC0 9F in COVID-19 infections [1] Updated 16 Apr 2020
17 Feb 2020 Licensing Status ASC 09/ritonavir is available for licensing as of 17 Feb 2020. http://ascletis.com.cn/single3/136.html Updated 27 Feb 2020
15 Feb 2020 Phase Change - II Phase-II clinical trials in COVID-2019-infections (Combination therapy) in China (PO) (ChiCTR2000029759) Updated 27 Feb 2020
10 Feb 2020 Trial Update Ascletis Pharmaceuticals and First Affiliated Hospital of Zhejiang University plans a phase II trial for COVID-2019-infections (In adults, In the elederly) in China (PO) (NCT04261907) Updated 27 Feb 2020
07 Feb 2020 Trial Update Tongji Hospital plans a phase III trial for COVID-2019-infections (Combimation therapy) (PO) (NCT04261270) Updated 27 Feb 2020
06 Feb 2020 Phase Change - I Phase-I clinical trials in COVID-2019-infections (In adults, In the elederly) in China (PO) (ChiCTR2000029603) Updated 27 Feb 2020
06 Feb 2020 Phase Change - Preclinical Preclinical trials in COVID-2019-infections in China (PO) before February 2020 Updated 27 Feb 2020

References

  1. Ascletis Receives IND Approval for its HIV Drug ASC09F.

    Media Release
  2. A multicenter, randomized, open label, controlled trial for the efficacy and safety of ASC09/ Ritonavir compound tablets and Lopinavir/ Ritonavir (Kaletra) and Arbidol tablets in the treatment of novel coronavirus pneumonia (COVID-19)

    ctiprofile
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