COVI-DROPS (STI-2099) / Sorrento - LARVOL DELTA

Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (UK) (clinicaltrials.gov) - P2 | N=179 | Terminated | Sponsor: Sorrento Therapeutics, Inc. | N=350 ➔ 179 | Trial completion date: Mar 2023 ➔ May 2022 | Active, not recruiting ➔ Terminated; Study was terminated at interim analysis due to drops not working on new variants

Enrollment change • Trial completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (UK) (clinicaltrials.gov) - P2 | N=350 | Active, not recruiting | Sponsor: Sorrento Therapeutics, Inc. | Trial completion date: Dec 2022 ➔ Mar 2023

Trial completion date • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (UK) (clinicaltrials.gov) - P2 | N=350 | Active, not recruiting | Sponsor: Sorrento Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2022 ➔ Jul 2022

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

Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US) (clinicaltrials.gov) - P2 | N=97 | Completed | Sponsor: Sorrento Therapeutics, Inc. | Not yet recruiting ➔ Completed | N=72 ➔ 97 | Trial completion date: Jun 2022 ➔ Jan 2022

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

US: Randomized Study to Evaluate Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With Mild COVID-19 Infection (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Sorrento Therapeutics, Inc. | N=1800 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease

US: Randomized Study to Evaluate Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With Mild COVID-19 Infection (clinicaltrials.gov) - P2; N=1800; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US) (clinicaltrials.gov) - P2; N=72; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.; Trial completion date: Jan 2022 ➔ Jun 2022

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

Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (UK) (clinicaltrials.gov) - P2; N=350; Recruiting; Sponsor: Sorrento Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • PCR

Sorrento Receives Authorization From the UK Regulatory Agency to Conduct a Phase 2 Clinical Trial for COVI-DROPS in an Outpatient Setting (GlobeNewswire) - P1, N=NA; "...the Medicines and Healthcare products Regulatory Agency (MHRA), the United Kingdom’s regulatory agency, has cleared Sorrento’s COVI-DROPS product candidate for a Phase 2 efficacy trial....The application was supported by the safety data from a healthy subject study completed in the US, which showed a safety profile comparable to placebo with doses up to 60 mg. In this study, there were no serious adverse effects or dose limiting toxicities and all adverse effects were mild in severity. The maximum tolerated dose was not reached. The Phase 2 efficacy trial is a large double-blind clinical trial enrolling 350 outpatients with COVID-19 who are asymptomatic or have mild symptoms in a 2:2:1 randomization with patients receiving 10mg, 20mg or placebo...This trial will complement the Phase 2 trial currently being started in the US and a separate trial to be started in Mexico."

New P2 trial • P1 data • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US) (clinicaltrials.gov) - P2; N=72; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • PCR

Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (UK) (clinicaltrials.gov) - P2; N=350; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • PCR

Sorrento Receives US FDA Clearance to Proceed With Phase 1 Study for STI-2099 (Intranasal COVIDROPS) in Healthy Volunteers and Outpatient Treatment for Newly Diagnosed COVID-19 Positive Patients (GlobeNewswire) - "Initial trials are expected to be followed by a Phase 2 trial in both mild and moderate COVID-19 patients, either as a stand-alone nasal application or as a combination nasal and intravenous administration....It has received clearance from the FDA for its Investigational New Drug application (IND) for its Phase 1 study of the safety and pharmacokinetics of intranasal (IN) STI-2099 (COVIDROPS) in both healthy volunteers and patients with mild COVID-19....Sorrento is currently evaluating an intravenous formulation of this potent antibody, STI-2020 (IV)...This small volume IV-push formulation is being tested against the dominant strain of the SARS-CoV-2 virus in the U.S. as well as the emerging UK variant."

IND • New P1 trial • Trial status • Infectious Disease • Novel Coronavirus Disease

Sorrento Announces That Intranasal Administration of COVI-AMG Neutralizing Antibody Prevented COVID-19 Disease Progression in Infected Hamsters Following SARS-CoV-2 Infection (GlobeNewswire) - "Sorrento announced the enhancement of the clinical potential of this antibody by releasing in vivo data of intranasal COVI-DROPS (STI-2099)....The 500 µg single dose of STI-2020 (IV) or STI-2099 COVI-DROPS (IN) administered to the hamsters in the preclinical studies would be equivalent to a human dose of approximately 45 mg of antibody....Sorrento is in the final stages of cGMP manufacture of both forms of the antibodies and anticipates submitting IND filings for both intravenous STI-2020 and intranasal COVI-DROPS STI-2099 in November 2020."

IND • Preclinical • Infectious Disease • Novel Coronavirus Disease

Sorrento Announces IND Filing for COVI-DROPS, an Intranasal Formulation of a High Potency Neutralizing Antibody Against SARS-CoV-2 (GlobeNewswire) - "IND filing today for STI-2099 (COVI-DROPS™) for a phase 1 safety and pharmacokinetic study in healthy volunteers and outpatients with mild COVID-19 disease with or without a simultaneous intravenous injection of COVI-AMG™; Initial trial is expected to be followed by a phase 2 trial in both mild and moderate COVID-19 patients, either as a stand-alone nasal application or as a combination nasal and intravenous administration."

IND • Infectious Disease • Novel Coronavirus Disease