Sorrento Completes Successfully the SAD Study and Initiates the MAD Phase 1 Study with STI-1558, An Oral M(pro) Inhibitor as a Standalone Treatment and Prevention of COVID-19 without the Ritonavir as Booster
August 03 2022 - 9:00AM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced the completion of the SAD portion of the Phase 1 study of
its oral main viral protease (Mpro) inhibitor, the STI-1558.
The Phase 1 safety and PK study in healthy volunteers was
conducted in Australia. The MPR-COV-101AU study is entitled: “A
Randomized, Double-Blind, Placebo-Controlled, Phase I Study to
Assess the Safety, Tolerability, and Pharmacokinetics of Single and
Multiple Oral Doses of STI-1558 in Healthy Volunteers”. In the SAD
portion of the study, 4 dose-escalation cohorts (single oral dose
of 300, 600, 1200, and 2000 mg STI-1558 or placebo) with 8 subjects
in each cohort randomized 3:1 (except for Cohort 2 for the fasted
and fed dosing with 10 subjects randomized 4:1).
Only the preliminary blinded safety and PK data from the SAD
portion of the study is available. Overall, there were no changes
in vital signs, physical examinations, ECGs or safety clinical labs
resulting from study participation. The preliminary overall summary
of treatment-emergent adverse events (TEAEs), showed that there
were no serious AEs (SAEs) or severe TEAEs and the maximum
tolerated dose was not reached. No dose limiting toxicity was noted
and there were no premature terminations from the study post
treatment and no deaths during the study.
The linear and semi-log plots for doses from 300 mg to 1,200 mg
(Cohorts 1-3) are proportional and support a twice daily dose of
600 mg to maintain drug levels in plasma above EC90 of the
predicted value for viral inhibition. In rats, STI-1558 has showed
sufficient lung tissue penetration with 5.8-fold higher drug level
in lungs than in plasma, indicating a potential robust antiviral
activity in COVID-19 patients.
A high fat meal reduced Cmax and AUC, therefore it is
appropriate to take the STI-1558 capsules on an empty stomach twice
daily.
The multiple ascending dose (MAD) study is starting in
Australia. A large Phase 2 study is planned in Mexico that could
support an Emergency Use Authorization (EUA) in Mexico. Phase 2/3
trials in US and other major regions have also been planned once
the MAD part is successfully completed.
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 Abivertinib, 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 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 Sorrento’s products, technologies and prospects. 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; risks related
to Sorrento’s multiple ascending dose (MAD) Phase 1 Study with
STI-1558; 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 those for
STI-1558, may not be replicated in 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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