Sorrento Therapeutics (NASDAQ: SRNE, “Sorrento”) and Scilex
Holdings Company (“Scilex”), a majority owned subsidiary of
Sorrento, have entered into an exclusive licensing term sheet with
Aardvark Therapeutics (“Aardvark”) to acquire Aardvark’s
proprietary formulation, Delayed Burst Release Low Dose Naltrexone
(DBR-LDN), or ARD-301, for the treatment of chronic pain,
fibromyalgia, and chronic post-COVID syndrome (“long haul COVID” or
“long COVID”) in multiple Phase 2 programs planned to be initiated
this year.
Following execution of the definitive agreement between the
parties, Scilex plans to work with Aardvark to initiate a new Phase
2 trial this year for fibromyalgia, which Scilex believes will be
an important milestone for treating physicians, and most
importantly for the estimated 10 million U.S. adults suffering from
this chronic, frequently debilitating central pain condition with
limited treatment options.1 Approximately one-third of those
diagnosed with fibromyalgia in the U.S. are reported to receive
chronic prescription opioids, which is part of the opioid crisis,
since opioids are not believed to be an effective solution for
chronic central pain.2 ARD-301 is comprised of a non-opioid,
non-addictive therapy option that has been shown to have activity
for improving a broad array of fibromyalgia symptoms in prior
clinical studies with LDN. Currently, there are only three FDA
approved pharmacologic treatments for fibromyalgia, but they have
demonstrated limited efficacy and burdensome side effects in many
patients.
COVID-19 is a global public health crisis with severe and
potentially long-lasting effects. COVID-19 patients around the
world have reported persistent suffering, including serious
complications that can last for months after the acute infection
resolves, and – even with vaccines – there is great a need for
treatment options for Long Haul COVID. According to a
research letter published in the Journal of the American Medical
Association (JAMA), more than 40 percent of COVID-19 survivors
assessed in an Italian study still reported shortness of breath an
average of 60 days following symptom onset.3 These data suggest
that a significant percentage of COVID-19 survivors may be at risk
for respiratory complications and other sequelae, which is a
condition that is now colloquially referred to as “Long COVID.” “I
look forward to working with Sorrento, Scilex Holding, and Aardvark
Therapeutics to initiate a Phase 2 trial to explore potential
benefit of ARD-301 for patients suffering from the sequelae of
chronic post-COVID syndrome,” said Stephen Faraone, Ph.D.,
Distinguished Professor and Vice Chair for Research, Department of
Psychiatry, SUNY Upstate Medical University, Syracuse, New
York.
“We at Scilex are very excited to license from Aardvark a
meaningful non-opioid therapeutic option that is desperately needed
for millions of people in the US and around the world who will
develop fibromyalgia or the critical complications of COVID-19
disease where very few treatments exist,” said Jaisim Shah,
President and CEO of Scilex. “As increasing numbers of patients
suffer from uncontrolled chronic pain resulting from dysregulation
of pain signaling, we look forward to helping advance both clinical
programs with Scilex’s team to address these high unmet needs,”
commented Tien Lee, MD, Chief Executive Officer of Aardvark
Therapeutics. Dr. Brian Johnson, professor of psychiatry and
anesthesia at SUNY Upstate Medical University, states, “it is very
encouraging to see development of an innovative low-dose naltrexone
formulation to address fibromyalgia, a condition for which there is
a need for better pharmacotherapies.”
About Sorrento Therapeutics
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to treat cancers
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"), 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. SP-102 is undergoing a
Phase 3 pivotal trial for the treatment of lumbosacral radicular
pain/sciatica.
For more information visit www.sorrentotherapeutics.com.
About Scilex Holding Company
Scilex Holding Company, a majority-owned subsidiary of Sorrento,
is a commercial-stage, non-opioid pain management company focused
on the development and commercialization of topical and injectable
therapies. Scilex targets indications with high unmet needs and
large market opportunities with non-opioid therapies for the
treatment of patients with moderate to severe chronic pain. Scilex
launched its first commercial product in October 2018 and is
developing its late-stage pipeline, which includes a pivotal Phase
3 candidate and a Phase 2 candidate. Its commercial product,
ZTlido® (lidocaine topical system) 1.8%, or ZTlido®, is a
prescription lidocaine topical product approved by the U.S. Food
and Drug Administration for the relief of pain associated with
postherpetic neuralgia, which is a form of post-shingles nerve
pain. Scilex’s two product candidates are SP-102 (10 mg,
dexamethasone sodium phosphate viscous gel), or SEMDEXA™, a Phase
3, novel, viscous gel formulation of a widely used corticosteroid
for epidural injections to treat lumbosacral radicular pain, or
sciatica with FDA Fast Track status, and SP-103 (lidocaine topical
system) 5.4%, or SP-103, a Phase 2, next-generation,
triple-strength formulation of ZTlido®, for the treatment of low
back pain.
For more information visit www.scilexpharma.com.
About Aardvark Therapeutics
Aardvark Therapeutics is a clinical stage biotechnology company
focused on the development of novel small molecule therapeutics to
activate innate homeostatic pathways for the treatment of metabolic
diseases, inflammation, and other indications.
For more information visit www.aardvarktherapeutics.com.
About Fibromyalgia
Fibromyalgia is a chronic condition associated with widespread
pain and tenderness, as well as general fatigue. Fibromyalgia is
considered by many to be a condition that is largely mediated in
the central nervous system, given that fibromyalgia sufferers often
present without a direct peripheral insult or injury. People
suffering from fibromyalgia also often experience sleep disruption,
depressed mood, and cognitive impairment. It is estimated that, in
the United States, fibromyalgia affects more than 10 million
people. Currently, there are only three FDA-approved pharmacologic
treatments for fibromyalgia, but they have limited efficacy and
burdensome side effects in many patients.
Forward-Looking Statements
This press release and any statements made for and during any
presentation or meeting concerning the matters discussed in this
press release contain forward-looking statements related to
Sorrento Therapeutics, Inc. and its subsidiaries, including but not
limited to Scilex, under the safe harbor provisions of Section 21E
of the Private Securities Litigation Reform Act of 1995 and are
subject to risks and uncertainties that could cause actual results
to differ materially from those projected. Forward-looking
statements include statements regarding the proposed agreement
between Sorrento, Scilex and Aardvark regarding the proposed
license and acquisition ARD-301 for the treatment of chronic pain,
fibromyalgia, and chronic post-COVID syndrome, the prospects for
ARD-301 and Scilex’s plans to initiate [a] new Phase 2 trial[s]
this year for fibromyalgia. 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 the risk that the parties do not enter into
a definitive agreement or close the proposed transaction, the risk
that ARD-301 does not meet the parties’ objectives and the risk
that Scilex does not commence [a] Phase 2 trial[s] for fibromyalgia
in 2021 or at all. 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 may be required by law.
Media and Investor Relations
Contact: Alexis Nahama, DVM
Telephone: 1.858.203.4120
Email: mediarelations@sorrentotherapeutics.com
Website: www.sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered trademarks of
Sorrento Therapeutics, Inc.
ZTlido® and G-MAB™ are trademarks owned by Scilex
Pharmaceuticals Inc. and Sorrento, respectively.
SEMDEXA™ (SP-102) is a trademark owned by Scilex Holding. A
proprietary name review by the FDA is planned.
Seprehvir® is a registered trademark of Virttu Biologics
Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and
part of the group of companies owned by Sorrento Therapeutics,
Inc.
All other trademarks are the property of their respective
owners.
© 2021 Sorrento Therapeutics, Inc. All Rights Reserved.
References
- National Fibromyalgia Association
(https://fmaware.net/fibromyalgia-prevalence/)
- Mary-Ann Fitzcharles, Neda Faregh,
Peter A. Ste-Marie, Yoram Shir, "Opioid Use in Fibromyalgia Is
Associated with Negative Health Related Measures in a Prospective
Cohort Study", Pain Research and Treatment, vol. 2013, Article ID
898493, 7 pages, 2013.
- Carfì, A., Bernabei, R., &
Landi, F. (2020). Persistent Symptoms in Patients After Acute
COVID-19. Jama, 324(6), 603. doi:10.1001/jama.2020.12603
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