Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced that 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 submitted as a rolling application and
the MHRA cleared the study in less than a month from Sorrento’s
first submission to the MHRA. 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 (details can be found
on www.ClinicalTrials.gov using the identifier NCT04900428). This
trial will complement the Phase 2 trial currently being started in
the US and a separate trial to be started in Mexico.
COVI-DROPS is administered as an intranasal
instillation in each nares to recently infected patients and
utilizes the same neutralizing antibody drug substance as COVI-AMG,
the intravenous formulation. The antibody is active against the
original SARS-CoV-2 virus as well as the most prevalent viral
variants of concern (VoCs) currently infecting the UK and the US.
These variants include the UK/Alpha and the India/Delta variants of
concern.
The results of this Phase 2 trial in the UK will
be combined with the results of the US and Mexico Phase 2 trials
and should the results of these studies demonstrate that COVI-DROPS
is both safe and effective against SARS-CoV-2, Sorrento will apply
for Emergency Use Authorization in the US, India, UK, Mexico and
European Union as well as other territories.
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)
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 COVIDROPS 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 COVIDROPS 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
ContactAlexis 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.
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