Ovydso (olgotrelvir) / Sorrento - LARVOL DELTA

Olgotrelvir as a Single-Agent Treatment of Nonhospitalized Patients with Covid-19. (PubMed, NEJM Evid) - P3 | "Olgotrelvir as a single-agent treatment significantly improved symptom recovery. Adverse effects were not dose limiting. (Funded by Sorrento Therapeutics, a parent company of ACEA Therapeutics; ClinicalTrials.gov number, NCT05716425.)."

Clinical • Journal • P3 data • Dermatology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

How To Measure Benefit in a Changing Pandemic - Olgotrelvir for SARS-CoV-2. (PubMed, NEJM Evid) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Olgotrelvir as a Standalone Treatment for Nonhospitalized Covid-19 Patients: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial (ASM Microbe 2024) - "Olgotrelvir showed enhanced oral bioavailability in animal models and in humans, with significant plasma and lung tissue exposures without the need for coadministration of ritonavir, a potent CYP3A4 inhibitor. The baseline characteristics of 1212 patients recruited between Feb. 8 and Jun 26, 2023 were similar in the two groups. Most patients (98·7%) were either vaccinated or previously infected with SARS-CoV-2."

Clinical • P3 data • Dermatology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

An Oral Antiviral Olgotrelvir with Dual Inhibitory Activities of SARS CoV-2 Mpro and Cathepsin L as a Standalone Intervention Candidate for COVID-19 (ASM Microbe 2024) - "Additionally, AC1115 demonstrated potent activity against the Mpro E166 mutants which are resistant to nirmatrelvir. For COVID-19 patients in phase I study, oral treatment with olgotrelvir at 300, 600 or 800mg BID demonstrated fast reductions of viral RNA copies compared with placebo control at D3 (two days of treatment) in each dose group. In conclusion, olgotrelvir displayed potent and broad-spectrum anti-SARS-CoV-2 activity, and demonstrated favorable safety profile and antiviral activity as a standalone oral treatment for COVID-19."

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Olgotrelvir as a standalone treatment for non-hospitalised COVID-19 patients: a Phase 3, double-blind, randomised, placebo-controlled trial (ECCMID 2024) - No abstract available

Clinical • Late-breaking abstract • P3 data • Infectious Disease • Novel Coronavirus Disease

On the origins of SARS-CoV-2 main protease inhibitors. (PubMed, RSC Med Chem) - "In less than 3 years of research, 4 inhibitors of SARS-CoV-2-M have actually been authorized for COVID-19 treatment (nirmatrelvir, ensitrelvir, leritrelvir and simnotrelvir) and more such as EDP-235, FB-2001 and STI-1558/Olgotrelvir or five undisclosed compounds (CDI-988, ASC11, ALG-097558, QLS1128 and H-10517) are undergoing clinical trials. Since many series of covalent SARS-CoV-2-M inhibitors owe some of their origins to previous work on other proteases, we first provided a description of various inhibitors of cysteine-bearing human caspase-1 or cathepsin K, as well as inhibitors of serine proteases such as human dipeptidyl peptidase-4 or the hepatitis C protein complex NS3/4A. This is then followed by a description of the results of the approaches adopted (repurposing, structure-based and high throughput screening) to discover coronavirus main protease inhibitors."

Journal • Review • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • CASP1 • CTSK • SPECC1

Olgotrelvir, a dual inhibitor of SARS-CoV-2 M and cathepsin L, as a standalone antiviral oral intervention candidate for COVID-19. (PubMed, Med) - P1 | "Olgotrelvir is an oral inhibitor targeting M and CTSL with high antiviral activity and plasma exposure and is a standalone treatment candidate for COVID-19."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Bioequivalence Trial of Fasting Single Oral STI-1558 Capsule in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

[14C] Study on Mass Balance and Biotransformation of STI-1558 in Healthy Chinese Adult Male Subjects (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Relative Bioavailability of STI-1558 and the Effect of Itraconazole and Rifampin on the Pharmacokinetics of STI-1558 (clinicaltrials.gov) - P1 | N=37 | Completed | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Mar 2027 ➔ Nov 2023 | Trial primary completion date: Mar 2025 ➔ Mar 2023

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia

Study to Access the Efficacy and Safety of STI-1558 in Adult Subjects With Mild or Moderate (COVID-19) (clinicaltrials.gov) - P3 | N=1218 | Completed | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. | Recruiting ➔ Completed | Trial completion date: Jan 2024 ➔ Jul 2023 | Trial primary completion date: Jan 2024 ➔ Jul 2023

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

A Bioequivalence Trial of Fasting Single Oral STI-1558 Capsule in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd.

New P1 trial • Infectious Disease • Novel Coronavirus Disease

Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients (clinicaltrials.gov) - P1 | N=79 | Completed | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

[14C] Study on Mass Balance and Biotransformation of STI-1558 in Healthy Chinese Adult Male Subjects (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Relative Bioavailability of STI-1558 and the Effect of Itraconazole and Rifampin on the Pharmacokinetics of STI-1558 (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Pneumonia

Study to Access the Efficacy and Safety of STI-1558 in Adult Subjects With Mild or Moderate (COVID-19) (clinicaltrials.gov) - P3 | N=1200 | Recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease

[14C] Study on Mass Balance and Biotransformation of STI-1558 in Healthy Chinese Adult Male Subjects (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd.

New P1 trial • Infectious Disease • Novel Coronavirus Disease

Study to Access the Efficacy and Safety of STI-1558 in Adult Subjects With Mild or Moderate (COVID-19) (clinicaltrials.gov) - P3 | N=1200 | Not yet recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd.

New P3 trial • Infectious Disease • Novel Coronavirus Disease

Study to Assess the Safety, Tolerability and Pharmacokinetics of STI-1558 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=58 | Completed | Sponsor: Sorrento Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Relative Bioavailability of STI-1558 and the Effect of Itraconazole and Rifampin on the Pharmacokinetics of STI-1558 (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd.

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia

Study to Assess the Safety, Tolerability and Pharmacokinetics of STI-1558 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=58 | Active, not recruiting | Sponsor: Sorrento Therapeutics, Inc. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Nov 2022 ➔ Feb 2023

Enrollment closed • Trial completion date • Infectious Disease • Novel Coronavirus Disease

Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients (clinicaltrials.gov) - P1 | N=88 | Recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients (clinicaltrials.gov) - P1 | N=88 | Not yet recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd.

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study to Assess the Safety, Tolerability and Pharmacokinetics of STI-1558 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=58 | Not yet recruiting | Sponsor: Sorrento Therapeutics, Inc. | Initiation date: May 2022 ➔ Aug 2022

Trial initiation date • Infectious Disease • Novel Coronavirus Disease