Sorrento Announces Completion of Enrollment in US Phase 2 Clinical Trial for COVI-DROPS and Achievement of Interim Analysis Threshold in the UK

Rhea-AI Summary

Sorrento Therapeutics (SRNE) has announced the completion of enrollment for its US Phase 2 study of COVI-DROPS™, a neutralizing antibody treatment for COVID-19 outpatients, enrolling 72 individuals. This study aims to assess the efficacy of three dosage levels (10 mg, 20 mg, and 40 mg) against viral load reduction. Additionally, the UK Phase 2 trial has achieved 50% enrollment with 175 participants. Both trials have shown COVI-DROPS to be well tolerated with no significant safety concerns reported so far. Results from these trials are expected in the coming months.

Positive

• Completion of enrollment in US Phase 2 trial with 72 participants.
• COVI-DROPS demonstrates efficacy against multiple SARS-CoV-2 variants, including Delta.
• No significant safety events reported in either trial.
• UK trial reached 50% enrollment, indicating strong interest in the treatment.

Negative

• None.

• COVID-19 patients with newly diagnosed SARS-CoV-2 infections were treated in these randomized, double-blind, placebo-controlled Phase 2 trials in the US and UK.
  
  
• COVI-DROPS™ neutralizing antibody was administered as a single low dose intranasal instillation.
  
  
• Results indicate COVI-DROPS is highly active against the original SARS-CoV-2 virus, as well as the variants of concern including highly transmissible and virulent Delta variant the dominant strain during the conduct of the trial.
  

SAN DIEGO, Jan. 19, 2022 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that the US Phase 2 study (www.ClinicalTrials.gov  NCT04906694) with intranasal COVI-DROPS treatment in COVID-19 outpatients has completed enrollment. This preliminary efficacy study enrolled 72 adult outpatients who received a single administration of 10 mg, 20 mg or 40 mg COVI-DROPS or placebo, randomized 1:1:1:1. The primary endpoint was viral load reduction from baseline. Key secondary endpoints included the proportion of subjects with medically-attended visits or hospitalizations and the change from baseline in the WHO Clinical Progression Scale score. There were no significant safety events reported during this study.

Additionally, Sorrento is pleased to announce that the UK Phase 2 study (www.ClinicalTrials.gov  NCT04900428) of intranasal COVI-DROPS treatment in COVID-19 outpatients who are asymptomatic or have mild symptoms has reached the interim analysis threshold of 50% enrollment (n=175). In this study, outpatient adults received a single instillation of 10 mg or 20 mg COVI-DROPS or placebo with a randomization of 2:2:1. The primary efficacy endpoint in the UK study is viral load reduction from baseline and key secondary endpoints also are similar to the US study. Unlike the US study, this study uses a decentralized design where patients are assessed and treated in their homes. COVI-DROPS has also been well tolerated in this study.

We anticipate reporting on the results from both the US trial and the interim analysis of the UK trial in the coming months. The results of these Phase 2 trials will be combined with the results from the planned Phase 2 trials in Mexico which enrolls children as well as adults.

In contrast to some of the current EUA approved high dose neutralizing antibodies given by IV infusion or subcutaneous injection, COVI-DROPS is administered as a simple intranasal instillation into each nostril to recently infected subjects. The neutralizing antibody (nAb) in COVI-DROPS is the same antibody as in COVI-AMG, which is a high potency/low dose IV push injection. This nAb was active in vitro and in animal models of COVID-19 infection against the SARS-CoV-2 variants of concern (VoCs) including the highly transmissible and virulent India/Delta variant, as well as the UK/Alpha variant and the original SARS-CoV-2 virus.

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 COVI-DROPS™; 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) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on February 28, 2018.

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 activity of COVI-DROPS against SARS-CoV-2, including the original SARS-CoV-2 virus, the UK/Alpha and the India/Delta variants, and any other VoCs; 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, the US and Mexico; the potential efficacy and safety of COVI-DROPS and Sorrento’s plans to apply for Emergency Use Authorization in the US, India, UK, European Union or any other territories. 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 COVI-DROPS; 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
Dorman Followwill
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™, COVI-DROPS™, 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.

©2022 Sorrento Therapeutics, Inc. All Rights Reserved.

FAQ

What are the results of the US Phase 2 study for COVI-DROPS (SRNE)?

The US Phase 2 study of COVI-DROPS is completed with 72 participants enrolled, focusing on viral load reduction as the primary endpoint. Results will be reported in the coming months.

How many participants are involved in the UK Phase 2 trial for COVI-DROPS (SRNE)?

The UK Phase 2 trial has reached 50% enrollment with 175 participants, focusing on asymptomatic or mildly symptomatic COVID-19 outpatients.

What is the primary endpoint of the COVI-DROPS Phase 2 trials (SRNE)?

The primary endpoint for both the US and UK Phase 2 trials is the reduction of viral load from baseline in COVID-19 patients.

What does the COVI-DROPS treatment entail (SRNE)?

COVI-DROPS is administered as a single low-dose intranasal instillation, differing from traditional high-dose neutralizing antibodies that require IV infusion.

When can we expect results from the COVI-DROPS trials (SRNE)?

Results from both the US and UK Phase 2 trials of COVI-DROPS are anticipated to be reported in the coming months.