Sorrento Therapeutics Announces First Subject Dosed in a Phase I Clinical Study of STI-1558, an Oral Mpro Inhibitor as a Standalone Treatment and Prevention of COVID-19 Without Co-Administration of Ritonavir Booster
June 03 2022 - 9:20AM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced the first subject was dosed in a Phase I clinical study
(NCT05364840) of its oral main viral protease
(Mpro) inhibitor, STI-1558.
The world has been experiencing repeated waves of infection of
SARS-CoV-2 and its continually emerging variants. Current vaccines
and EUA-approved antibodies offer diminished protection against
transmission and infection by Omicron variants. Oral antiviral
drugs with broad-spectrum antiviral activities and limited
potential for drug-drug interaction risks are still urgently
needed. EUA-cleared Nirmatrelvir (Paxlovid) has demonstrated
encouraging data in preventing disease progression; however, in
order to achieve therapeutic blood level, it requires the
co-administration or “boosting” with Ritonavir, a strong inhibitor
of cytochrome P450 (CYP) 3A4 (“CYP3A4"). This means it blocks the
liver from metabolizing drugs that utilize this enzyme for
metabolism and clearance, resulting in the potential for
significant drug-drug interactions, which can limit its use,
especially in at-risk patients on multiple medications.
STI-1558 is a potent Mpro inhibitor with an IC50 value of
2.7 nM and has demonstrated potent antiviral activity against all
COVID-19 variants studied, including Omicron, with an IC90 value
between 14 nM and 41 nM (an IC50/IC90 is the concentration of drug
need to produce a 50%/90% inhibition of activity) in vitro
following infection of human bronchial epithelial cells. It is also
a Cathepsin L inhibitor, which may block effective viral entry into
host cells. In preclinical studies, STI-1558 showed an oral
antiviral activity against SARS-CoV-2 in a humanized transgenic
mice model. In these preclinical studies, STI-1558 protected virus
infected mice from weight loss, viral replication in lungs, as well
as associated lung pathology. STI-1558 possesses excellent
off-target selectivity, is metabolically stable in human liver
microsomes, and has demonstrated oral bioavailability of up to 85%
in dogs and monkeys. In GLP repeat-dose toxicology studies in rats
and dogs, there have been no significant safety findings to date,
including blood chemistry, hematology and histopathology at daily
doses of up to 2000 mg/kg and 300 mg/kg, respectively. Based on the
safety and pharmacokinetic modeling, Sorrento expects the human
efficacious dose to be between 300 mg and 600 mg BID without the
need for a Ritonavir-boost.
The Phase I study will be conducted in Australia will evaluate
the safety, tolerability, and pharmacokinetics of STI-1558 in
single ascending doses (SAD) followed by multiple ascending doses
(MAD) compared to placebo in healthy volunteers. A global pivotal
Phase II/III trial will be initiated as soon as possible following
the successful completion of the Phase I. “We are excited to reach
the milestone of advancing STI-1558 to the clinical stage. With
data achieved from the preclinical studies and potential standalone
treatment without requiring a pharmacokinetic booster, STI-1558 has
the potential to be a best-in-class oral antiviral therapeutic for
COVID-19, appropriate for patients taking multiple medications,
without requiring extra monitoring or dose adjustments. Sorrento
has initiated a large-scale manufacture synthesis for API and drug
product to prepare for global commercial supply if STI-1558 is
successfully developed. Sorrento continues its commitment to
develop and deliver effective anti-COVID-19 therapies to save
patient lives and end the pandemic,” stated Dr. Henry Ji,
Chairman 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 potential for STI-1558 to effectively
inhibit viral entry and replication, weight loss and lung
pathology; the oral bioavailability of STI-1558; the potential
success of the Phase I trial; the expected timing of a global Phase
II/III 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 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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