ASC 09/ritonavir - Ascletis Pharmaceuticals
Alternative Names: ASC 09F; ASC-09/ritonavir; Ritonavir/ASC-09Latest Information Update: 27 Jul 2022
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
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
- Available For Licensing Yes
Highest Development Phases
- Discontinued COVID-19 pneumonia; HIV infections
Most Recent Events
- 27 Jul 2022 Discontinued - Phase-I for COVID-19 pneumonia (In the elderly, In adults) in China (PO)
- 27 Jul 2022 Discontinued - Phase-II for COVID-19 pneumonia (Combination therapy) in China (PO)
- 27 Jul 2022 Discontinued - Phase-II for HIV infections in China (PO)
Development Overview
Introduction
An orally administered, fixed dose combination of ASC 09 [see Adis Insight Drug profile800031712] and ritonavir [see Adis Insight Drug profile800004117] was being developed by Ascletis Pharmaceuticals for the treatment of COVID-19 pneumonia and HIV infections. ASC 09, a protease inhibitor, was reported to have high antiviral potency and a high genetic barrier to resistance. Ritonavir is a small molecule of CYP3A4 inhibitor. Clinical development was ongoing in China. However, as of July 2022, development of the fixed dose combination has been discontinued as it is no more listed on Ascletis Pharmaceuticals' pipeline.
Key Development Milestones
As of July 2022, development of ASC 09/ritonavir fixed dose combination has been discontinued as it is no more listed on Ascletis Pharmaceuticals' pipeline (Ascletis Pharmaceuticals pipeline, July 2022).
Ascletis Pharmaceuticals, in December 2020, completed a phase I pharmacokinetic trial that evaluated the pharmacokinetic parameters of ASC0 9F after multiple oral dosing (NCT04547894; ASC-ASC09F-I-CTP-01). This open-label trial was initiated in November 2020 and recruited 12 healthy volunteers, aged 18-45 years in China [1] .
In April 2020, Ascletis Pharma received IND approval from National Medical Products Administration (NMPA) for ASC0 9F (ASC09/ritonavir ifxed-dose combination) [2]
As of April 2020, phase II development of ASC0 9F was underway for treatment of HIV infections [2] (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-19 pneumonia (ChiCTR2000029759). The randomised trial intends to enrol approximately 60 patients in China [3] .
In March 2022, The First Affiliated Hospital of Zhejiang University School of Medicine terminated an early phase I trial which was design to compare the safety and efficacy of ASC 09/ritonavir and lopinavir/ritonavirin patients with COVID-2019 pneumonia (ASC09F-CTP-ZY01; ChiCTR2000029603; NCT04261907). The company terminated the trial due to slow accrual of patients. The randomised trial was initiated in February 2020 and enrolled six of total 80 patients in China [4] .
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-19 pneumonia | With Interferon aerosol | Combination therapy | Discontinued (II) | China | PO / Tablet | The Second Affiliated Hospital of Chongqing Medical University | 27 Jul 2022 |
| COVID-19 pneumonia | - | In adults, In the elderly | Discontinued (I) | China | PO / Tablet | The First Affiliated Hospital of Zhejiang University School of Medicine | 27 Jul 2022 |
| HIV infections | - | - | Discontinued (II) | China | PO / Tablet | Ascletis | 27 Jul 2022 |
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 |
|---|---|---|
| 27 Jul 2022 | Phase Change - Discontinued(I) | Discontinued - Phase-I for COVID-19 pneumonia (In the elderly, In adults) in China (PO) Updated 27 Jul 2022 |
| 27 Jul 2022 | Phase Change - Discontinued(II) | Discontinued - Phase-II for COVID-19 pneumonia (Combination therapy) in China (PO) Updated 27 Jul 2022 |
| 27 Jul 2022 | Phase Change - Discontinued(II) | Discontinued - Phase-II for HIV infections in China (PO) Updated 27 Jul 2022 |
| 23 Mar 2022 | Trial Update | Ascletis Pharmaceuticals terminates a phase I trial in COVID-19 pneumonia (In adults, In the elederly) in China due to slow accrual of patients (PO) (ChiCTR2000029603) (NCT04261907) Updated 15 Apr 2022 |
| 07 Dec 2020 | Trial Update | Ascletis completes a phase I pharmacokinetic trial (In volunteers) in China (PO, Tablet) (NCT04547894) Updated 20 Jan 2021 |
| 09 Nov 2020 | Trial Update | Ascletis initiates a phase I pharmacokinetic trial In volunteers) in China (PO, Tablet) (NCT04547894) Updated 20 Jan 2021 |
| 16 Sep 2020 | Trial Update | Ascletis plans a phase I trial (In volunteers) in China (PO, Tablet) (NCT04547894) Updated 16 Sep 2020 |
| 13 Apr 2020 | Phase Change - II | Phase-II clinical trials in HIV infections in China (PO) [2] Updated 16 Apr 2020 |
| 13 Apr 2020 | Regulatory Status | National Medical Products Administration (NMPA) approves IND application for ASC0 9F in COVID-19 pneumonia [2] 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 24 Feb 2020 |
| 15 Feb 2020 | Phase Change - II | Phase-II clinical trials in COVID-19 pneumonia(Combination therapy) in China (PO) (ChiCTR2000029759) Updated 24 Feb 2020 |
| 10 Feb 2020 | Trial Update | Ascletis Pharmaceuticals and First Affiliated Hospital of Zhejiang University plans a phase II trial for COVID-19 pneumonia (In adults, In the elederly) in China (PO) (NCT04261907) Updated 17 Feb 2020 |
| 07 Feb 2020 | Trial Update | Tongji Hospital plans a phase III trial for COVID-19 pneumonia (Combimation therapy) (PO) (NCT04261270) Updated 19 Feb 2020 |
| 06 Feb 2020 | Phase Change - I | Phase-I clinical trials in COVID-19 pneumonia (In adults, In the elederly) in China (PO) (ChiCTR2000029603) Updated 17 Feb 2020 |
| 06 Feb 2020 | Phase Change - Preclinical | Preclinical trials in COVID-19 pneumonia in China (PO) before February 2020 Updated 17 Feb 2020 |
References
-
A Study to Evaluate the Pharmacokinetics of ASC09F in Healthy Subjects After Multiple Doses
ctiprofile -
Ascletis Receives IND Approval for its HIV Drug ASC09F.
Media Release -
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 -
A Randomized, Open-label, Multi-centre Clinical Trial Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Confirmed Cases of Pneumonia Caused by Novel Coronavirus Infection
ctiprofile
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