Brazilian Health Regulatory Agency (ANVISA) Authorizes Sorrento Therapeutics’ Large Phase 2 Clinical Trial of Abivertinib i...
15 October 2020 - 2:56AM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today
announced receipt of clearance from the Brazilian regulatory agency
(ANVISA) to proceed with a Phase 2 clinical trial of Abivertinib in
mild, moderate and severe COVID-19 patients.
The Brazil study is a Phase 2, Randomized, Double-Blind,
Placebo-controlled Study of the Safety and Efficacy of STI-5656
(Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19,
particularly looking at the potential clinical benefits of the drug
associated with its broad ability (mode of action) to reduce
inflammatory cytokine storm. The dose to be tested is the same as
in the U.S. Phase 2 trial, but the trial protocol in Brazil
includes patients at earlier stages of the disease, with a drug
administration regimen of only 7 days (versus 14 days for more
advanced patients in the U.S.).
The Brazilian study is expected to rapidly enroll 400 patients.
The rapid projected enrollment pace is made possible by the recent
partnership established between Sorrento and a leading local
clinical research organization (Synova Health) with access to high
quality medical centers throughout the country.
A broad clinical development strategic alignment between
Sorrento and local medical systems, including with the city of Rio
de Janeiro, will also help accelerate site initiation and access to
potential patients for additional Sorrento studies currently being
evaluated by ANVISA.
BR Protocol Design |
U.S.
Protocol Design |
Mild, Moderate and Severe COVID-19 patients |
Severe COVID-19 patients |
Any hospitalized patient |
ICU non-ventilated |
N=400 randomized 3:1 (Abivertinib to placebo) |
N=80 randomized
1:1 (Abivertinib to placebo) |
100 mg QD x 7 days |
100 mg QD x 14 days |
Duration 45 days |
Duration 94 days |
Primary endpoint: % discharged from hospital by
Week 4 |
Primary endpoint: % alive and free of respiratory
failure at Week 4 |
“We are very satisfied with the progress made in
Brazil so far,” stated Dr. Henry Ji, Chairman and CEO of Sorrento
Therapeutics. “By targeting some of the geographies currently most
impacted by COVID-19, we are able to implement a synergistic
program to answer questions about safety and efficacy of our drug
candidates in helping patients, while potentially accelerating
enrollment timelines, reducing overall cost and opening up
collaboration opportunities with local companies.”
The study is referenced with ANVISA (Brazilian authority) under
Process nº 25351.105670/2020-14, Reference n°
3380614/20-4
Brazilian Clinical Study details can be found
at:https://clinicaltrials.gov/ct2/show/NCT04528667?term=abivertinib&draw=2&rank=3
About Sorrento Therapeutics,
Inc. Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to treat
cancers. 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®", “Seprehvec™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™,
COVI-GUARD™, COVI-SHIELD™, COVI-AMG™ and T-VIVA-19™; and diagnostic
test solutions, including COVI-TRACK™, COVI-STIX™ and
COVI-TRACE™.
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 ZTlido® (lidocaine
topical system) 1.8% for the treatment of post-herpetic neuralgia.
RTX has completed a phase 1B trial for intractable pain associated
with cancer and a phase 1B trial in osteoarthritis patients.
ZTlido® was approved by the FDA on February 28, 2018.
For more information, visit
www.sorrentotherapeutics.com
Forward-Looking StatementsThis
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 Abivertinib, including the
safety, tolerability and demonstrated efficacy thereof; the
potential ability of Abivertinib to reduce inflammatory cytokine
activity; expected rapid enrollment of clinical trials in the U.S.
and Brazil; the protocol design for both the U.S. and Brazilian
clinical trials; the synergistic potential of the U.S. and Brazil
clinical trials; and the ability of a synergistic program to
potentially accelerate enrollment timelines, reduce overall cost
and create collaboration opportunities with local companies . 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 and its subsidiaries’, affiliates’ and
partners’ technologies and prospects and collaborations with
partners, including, but not limited to 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 the
company in the execution of its therapeutic product candidates
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, 2019, 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.
ContactAlexis Nahama, DVM (SVP
Corporate Development)Email:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.G-MAB™, COVI-GUARD™,
COVI-SHIELD™, COVI-AMG™, COVIDTRAP™, T-VIVA-19™, COVI-MAB™,
ACE-MAB™, COVI-TRACK™, COVI-STIX™ and COVI-TRACE™ are trademarks of
Sorrento Therapeutics, Inc.
ZTlido® is a trademark owned by Scilex
Pharmaceuticals Inc.All other trademarks are the property of their
respective owners. © 2020 Sorrento Therapeutics, Inc. All Rights
Reserved.
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