Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced the FDA clearance of a Phase 1 study of its oral main
viral protease (Mpro) inhibitor, STI-1558, in patients with
impaired renal and hepatic function.
A previously announced Phase 1 study of STI-1558 evaluating
single ascending doses (SAD), multiple ascending doses (MAD) and
food effect is proceeding in Australia, and the drug has been dosed
in patients in the first 3 cohorts with doses of 300, 600 and 1,200
mg. The study is currently dosing the final cohort in the study at
a dose of 2,000 mg per patient. STI-1558 has been well tolerated to
date with only a few related adverse events, all of which have been
transient, mild in severity and required no treatment.
To date, the PK profile has matched the predicted values based
on the animal studies, confirming that STI-1558 is readily absorbed
by humans with high bioavailability and indicating that there is no
need for ritonavir, a potent cytochrome P450 3A4 inhibitor, to
block metabolic clearance to maintain effective blood levels.
Avoiding coadministration of ritonavir significantly reduces the
potential for drug-drug interactions. PK modeling suggests that a
dose of 600 mg twice daily will maintain blood levels well above
the range necessary to effectively inhibit viral replication.
The Phase 1 study cleared by the FDA will examine the PK in
patients with moderate renal and hepatic impairment. Two doses of
STI-1558 (300 mg and 600 mg) will be studied in 12 subjects across
3 cohorts, 12 normal subjects, 12 renally-impaired subjects and 12
hepatically-impaired subjects, using a cross-over design. This is a
required study in the approval process and is expected to enable
Sorrento to proceed with the remaining studies that may be required
to apply for an Emergency Use Authorization for STI-1558 for the
treatment of COVID infections.
As soon as the SAD/MAD study is completed, Sorrento will prepare
for a global Phase 2 study in subjects with acute onset of symptoms
due to COVID-19. “STI-1558 has the potential to be a highly
effective antiviral treatment for acute COVID-19 and we look
forward to seeing how it performs in the Phase 1 study and the
planned Phase 2/3 study,” stated Henry Ji, Ph.D., Chairman,
President and CEO of Sorrento.
About Sorrento Therapeutics,
Inc.
Sorrento is a clinical and commercial stage biopharmaceutical
company developing new therapies to treat cancer, pain (non-opioid
treatments), autoimmune disease 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”),
immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates
(“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including Abivertinib, COVISHIELD™ and COVI-MSC™;
and diagnostic test solutions, including COVIMARK™.
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
postherpetic neuralgia (PHN). RTX has been cleared for a Phase II
trial for intractable pain associated with cancer and a Phase II
trial in osteoarthritis patients. Positive final results from the
Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel,
non-opioid product for the treatment of lumbosacral radicular pain
(sciatica), were announced in March 2022. 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 STI-1558, including the potential antiviral profile of
STI-1558 with respect to SARS-CoV-2 and its variants; the
preclinical testing of STI-1558; the potential safety and efficacy
of STI-1558; the potential that no co-administration will be
required with STI-1558; the bioavailability of STI-1558; the
potential success of the FDA-cleared Phase 1 trial and the ongoing
Phase 1 trial in Australia; the studies required to an Emergency
Use Authorization; the expected timing of a global Phase 2/3 trial;
STI-1558’s and Sorrento’s position in the antiviral industry; the
expected formulation, dosing and/or route of administration for
STI-1558; and the preparation of a global commercial supply of
STI-1558. 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 safety and efficacy of STI-1558
and seeking regulatory approval for STI-1558; 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, including PK modeling and predicted
values obtained therefrom, may not be replicated in, or consistent
with, continuing or 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 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, 2021 and subsequent Quarterly Report 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
RelationsContact: Brian CooleyEmail:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, Seprehvec™, SOFUSA™,
COVISHIELD™, COVIDROPS™, COVI-MSC™, COVIMARK™ and Fujovee™ are
trademarks of Sorrento Therapeutics, Inc.
SEMDEXA™ (SP-102) is a trademark of Semnur
Pharmaceuticals, Inc. A proprietary name review by the FDA is
planned.
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.
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