Sorrento Announces Dosing of COVID-19 Patients in Phase 2 Clinical Trial for COVIDROPS, a Highly Potent Neutralizing Antibody Against SARS-CoV-2 Including Delta and Alpha Variants of Concern, in an At-Home Outpatient Setting in United Kingdom
Sorrento Therapeutics has initiated a large Phase 2 clinical trial in the UK for its intranasal COVIDROPS™ neutralizing antibody treatment, enrolling approximately 350 outpatients with mild or asymptomatic COVID-19. The trial, which uses a decentralized design, evaluates doses of 10 mg and 20 mg against placebo. Previous safety studies indicated a favorable safety profile. If results are positive, Sorrento plans to apply for Emergency Use Authorization across multiple regions, including the US and EU. The antibody is effective against various SARS-CoV-2 variants, including Delta and Alpha.
- Initiation of Phase 2 efficacy trial for COVIDROPS in the UK.
- Approximately 350 patients to be enrolled, focusing on mild or asymptomatic cases.
- Previous safety studies indicated a comparable safety profile to placebo.
- Plans for Emergency Use Authorization in multiple regions upon favorable trial results.
- Dependence on trial results for future regulatory approvals.
- Risks related to clinical development and achieving study endpoints.
- COVID-19 patients with newly diagnosed SARS-CoV-2 infections were treated in this large Phase 2 efficacy trial in the United Kingdom.
- COVIDROPS™ neutralizing antibody is administered by intranasal instillation.
- COVIDROPS is highly active against the original SARS-CoV-2 virus, as well as the India/Delta and UK/Alpha variants currently prevalent in the UK and US.
SAN DIEGO, July 21, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that COVID-19 patients have been dosed in its Phase 2 efficacy trial. Approximately 350 outpatients with COVID-19 who are asymptomatic or have mild symptoms will be enrolled in this large double-blind, randomized clinical trial evaluating COVIDROPS doses of 10 mg or 20 mg against placebo (details can be found on www.ClinicalTrials.gov using the identifier NCT04900428). This study uses a novel decentralized design where subjects are assessed and treated in their homes and received a rapid review and clearance from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
A previously completed safety study conducted in the US at doses up to 60 mg in healthy subjects showed a comparable safety profile to placebo with all reported adverse effects being mild in severity. The UK study will complement Phase 2 trials currently being started in the US and should the results of these studies demonstrate that COVIDROPS is both safe and effective against SARS-CoV-2, Sorrento will apply for Emergency Use Authorization in the US, UK, Canada, India, Mexico and European Union as well as other territories.
COVIDROPS is administered as a simple intranasal instillation into each nostril to recently infected subjects. The neutralizing antibody drug substance is the same antibody as in COVI-AMG, which is a high potency/low dose IV push injection. The antibody is active in vitro and in animal models of COVID-19 infection against the SARS-CoV-2 variants of concern (VoCs) currently infecting the UK and the US, including the highly transmissible and virulent India/Delta variant, as well as the UK/Alpha variant and the original SARS-CoV-2 virus. Sorrento is developing a second neutralizing antibody with potential activity against all VoCs, including the Beta (South Africa) and Gamma (Brazil), for entry into the clinic and is intended for use as a cocktail for both intranasal and intravenous administration to augment the coverage of prevailing VoCs. Variants of interest, such as Lambda (Peru) and others are constantly evaluated in Sorrento’s active surveillance program.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVISTIX™ and COVITRACE™.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system)
For more information visit www.sorrentotherapeutics.com.
Forward-Looking Statements
This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the safety and efficacy of COVIDROPS against SARS-CoV-2, including the original SARS-CoV-2 virus, the UK/Alpha and the India/Delta variants, and any other variants of concern; the expected number of patients and doses in the planned Phase 2 trial in the UK; the expected outcome or results of the Phase 2 trials in the UK and the US; the potential efficacy and safety of COVIDROPS; Sorrento’s plans to apply for Emergency Use Authorization in the US, UK, Canada, India, Mexico, European Union or any other territories; Sorrento’s development of a second neutralizing antibody against all variants of concern for use as a cocktail therapy via intranasal or intravenous administration; and the active monitoring of emerging variants of concern, including the Lambda variant. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's technologies and prospects, including, but not limited to risks related to seeking regulatory approval for COVIDROPS; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results may not be replicated in future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its therapeutic antibody product candidate strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2020, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
Media and Investor Relations Contact
Alexis Nahama, DVM (SVP Corporate Development)
Email: mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™, COVITRACE™ and COVISTIX™ are trademarks of Sorrento Therapeutics, Inc.
SEMDEXA™ is a trademark of Semnur Pharmaceuticals, Inc.
ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc.
All other trademarks are the property of their respective owners.
©2021 Sorrento Therapeutics, Inc. All Rights Reserved.
FAQ
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