Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today
released unblinded Phase 1b study data of its oral main viral
protease (Mpro) inhibitor, OVYDSO™ (STI-1558) in COVID
patients.
This Phase 1b safety, PK and efficacy study in healthy
volunteers and COVID patients was conducted in China. The
study (MPR-COV-101CN) is entitled: “A Randomized, Double-Blind,
Placebo-Controlled, Phase I Study to Assess the Safety,
Tolerability, Pharmacokinetics and Efficacy of Single and Multiple
Oral Doses of STI-1558 in Healthy Volunteers and COVID
Patients”. In the SAD portion of the study, four
dose-escalation cohorts (single oral dose of 300, 600, 1200, and
2000 mg STI-1558 or placebo) were conducted with eight subjects in
each cohort – randomized 3:1. In the MAD portion of the study,
three dose-escalation cohorts with daily dose of 300 mg BID, 600 mg
BID or 800 mg BID for consecutive 7.5 days (total 15 doses) were
conducted with eight participants infected with SARS-CoV-2 in each
dose cohort – randomized 3:1 (active:placebo), and in the 600 mg
BID dose cohort, an additional 16 participants infected with
SARS-CoV-2 (10:6, active:placebo) were added as a cohort
extension.
The topline safety, PK and efficacy data from the SAD and MAD
portions of the study are now available. Overall, STI-1558 was
well-tolerated at these doses, with most subjects in both the SAD
and MAD portions of the study reporting no AEs. There was no dose
limiting toxicity during the study. There were no severe or serious
AEs, no premature discontinuations of STI-1558 due to an AE, and no
deaths. Most AEs were mild, transient, unrelated and required no
medical treatment.
A total of 12 subjects reported an AE in the SAD portion of the
study, with one AE of elevated blood thyroid-stimulating hormone
(TSH) deemed related to STI-1558 in the 2000 mg cohort. No
headaches were seen in this study. In the MAD portion of the study
in COVID-19 patients, 20 subjects from a total of 46 subjects
reported AEs, with only four subjects experiencing STI-1558-related
events. These four AEs included two subjects with mild or moderate
liver enzyme elevation (ALT/AST) without bilirubin elevation in the
300 BID and 800 BID cohorts, one subject with mild hyperuricemia in
the 600 mg BID cohort and one subject with mild rash in the 800 mg
BID cohort.
Antiviral activity was evaluated in the MAD portion of the study
in participants infected with SARS-CoV2 (300 mg BID, 600 mg BID and
800 mg BID daily for 7.5 days). The viral RNA load in participants
infected with SARS-CoV2 was measured by quantitative PCR. The viral
RNA load (log10 copies/ml) was significantly reduced in COVID-19
patients (n=29) treated with STI-1558 on Days 2, 4 and 6
post-treatment in comparison with placebo, indicating the strong
antiviral activity of STI-1558 in COVID-19 patients. Notably the
significant reduction of viral RNA (Log10 copies/ml) can be seen as
early as day 2 after being treated with STI-1558 at the likely
therapeutic dose of 600 mg BID (1.5 log lower than placebo,
p=0.036). These data demonstrate early antiviral activity of
STI-1558 in COVID-19 patients.
The PK profiles in the China trial were similar to the
Australian trial and the linear and semi-log PK plots for doses of
300 mg, 600 mg, 1200 mg and 2000 mg are proportional in the SAD
portion of study in healthy volunteers with AUC of 11.4 h* µg/mL,
24.0 h* µg /mL, 60.1 h* µg /mL and 84.4 h* µg /mL, respectively,
and the T1/2 is from 21.4 h to 24.5 h. In the MAD portion of the
study in COVID-19 patients, after 7.5 days of treatment (total of
15 doses), no accumulation was seen in all three MAD dose cohorts.
The trough concentrations (Ctrough) in 300 mg BID, 600 mg BID and
800 mg BID cohorts were 265 ng/mL, 431 ng/mL and 518 ng/mL,
respectively, similar to the trough concentrations in the
Australian trial in healthy volunteers (190 ng/mL, 354 ng/mL and
418 ng/mL). These Ctrough values are significantly above the EC90
value for viral inhibition in preclinical models.
Based on the safety and PK profiles and significant antiviral
efficacy in COVID-19 patients, a 600 mg twice-daily dose for 5 days
has been selected as a recommended dose for Phase 3 studies for the
standalone treatment of COVID-19.
After communication with the regulatory agency, a Phase 3
protocol was submitted to China NMPA. The Phase 3 trial
(MPR-COV-301CN) is entitled: “A Multicenter, Randomized,
Double-Blind, Placebo-Controlled, Phase III Study to Assess the
Efficacy and Safety of STI-1558 for Treatment of Mild and Moderate
Symptomatic Adults Infected with SARS-CoV-2”. Once cleared by NMPA,
the study, which plans to enroll 1200 COVID-19 patients, will be
subsequently commenced.
“We are excited to see the similarities of PK in the China study
and the Australian study. The significant antiviral effectiveness
and tolerability of OVYDSO in COVID patients suggests this compound
will significantly benefit patients and will require no boosting
with Ritonavir. We expect to initiate the Phase 3 trial very soon
in China, and meanwhile we are engaging with regulatory agencies on
a global Phase 2/3 trial design in order to initiate OVYDSO Phase
2/3 trials in Mexico and the U.S. as soon as possible,” stated
Henry Ji, Ph.D., 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 Abivertinib, next-generation tyrosine kinase
inhibitors (“TKIs”), 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 STI-1558, COVISHIELD™ and COVIDROPS™,
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 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 recommended dose for Phase 2/3
trials, the potential appropriateness of STI-1558 as a standalone
treatment for COVID-19, the potential initiation of the STI-1558
Phase 2/3 trials in Mexico, the U.S. and China, the global Phase
2/3 trial design, and the expected timing, number of patients to be
enrolled and other enrollment plans with respect to any Phase 2 or
3 trials for STI-1558. 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; 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 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
Contact: 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.
Grafico Azioni Sorrento Therapeutics (NASDAQ:SRNE)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Sorrento Therapeutics (NASDAQ:SRNE)
Storico
Da Giu 2023 a Giu 2024