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Sorrento Therapeutics
Announces Positive Phase 2a Clinical Trial Results for
Resiniferatoxin (RTX)
for the Treatment of Knee Pain in Moderate to Severe
Osteoarthritis of the Knee (OAK)
Patients
2023-09-07
·
BioSpace
临床2期
临床结果
临床3期
上市批准
All study objectives were met, demonstrating safety across dose groups and confirming efficacy and durability at the selected doses against placebo (
lidocaine
) and active control (steroid). All
RTX
RTX
doses (7.5 to 20 µg) were well-tolerated, with few severe or serious adverse events (AEs). The majority of reported AEs related to
pain
post-administration and resolved within hours following treatment. Very few severe AEs were reported across groups (including placebo) with no dose correlation.
RTX
post-injection administration
pain
was easily controlled.
RTX
20mcg dose outperformed all other dose groups (including the approved drug for this indication (intra-articular corticosteroids)) for efficacy and durability at and beyond 26 weeks post-treatment.
RTX
20mcg and 12.5mcg have been selected as the clinically optimal and minimally effective doses for further phase 2 pivotal or phase 3 trials. SAN DIEGO, Sept. 07, 2023 (GLOBE NEWSWIRE) --
Sorrento Therapeutics, Inc.
(OTC: SRNEQ, "
Sorrento
") announced today positive Phase 2a top-line clinical trial results for the
RTX
program. The Phase 2a study follows the positive observations from the Phase 1b/2 trial results (NCT03542838) of
RTX
Day 84 patient data, for which
Sorrento
has completed the one-year follow up for the last patient dosed in February 2021. The phase 2 trial, a multi-center, double blind, placebo- and active-controlled study, assessed the efficacy and safety of several dose groups of
RTX
RTX
to manage
pain
in patients with moderate-to-severe
OAK
(clinicaltrials.gov: NCT04885972). Given the durability of
OAK pain
relief response to
RTX
RTX
demonstrated in earlier phase 1b/2 trials,
Sorrento
decided to include an active approved comparator (
Zilretta
® intra-articular corticosteroids) in the current trial protocol. Top-Line Safety Outcomes (Summary) Generally, treatment was well-tolerated, with the most common noted AE being
pain
following topical
capsaicin
0.1% given to all patients for blinding purposes and study drug administration in the knee (across all dose groups). Very few serious AEs were noted across all dose groups, with one in particular (see below for additional detail) in the 15mcg
RTX
RTX
group being severe/life threatening (
hypertension
following drug administration), which resolved within hours with treatment of
pain
and no additional intervention. In the cases requiring pain control (any group) the dose of
opioid
was comparable. A few subjects in
RTX
groups required use of low dose oral opioids for up to 6 hours in some cases of prolonged moderate discomfort/
pain
. No patient required additional pain control or intervention after 6 hours or in the days following the day of administration and no patient left the clinic with opioids or an
opioid
prescription. A table accompanying this announcement is available at Subject 008-005, a 55-year-old female with a prior history of
hypertension (HTN)
and
morbid obesity
(BMI 46.9) developed elevated blood pressure about fourteen minutes post-
RTX
RTX
dose (208/147), which coincided with severe
pain
. The subject received
hydromorphone
0.8 and 0.4 mg IV and then
oxycodone
5 mg twice, and the
HTN
resolved without any other intervention. The
HTN
did not recur, and the subject’s ECG was normal. Discharge blood pressure was 140/74. Sponsor’s medical monitor disagreed with the characterization as life-threatening or an SAE as the clinic stay was not prolonged and the
HTN
required no treatment other than treating the subject’s
pain
. Sponsor also felt that the AE should have been considered a related event (marked unrelated by investigator). Top Line Efficacy and Durability Outcomes (Summary) The
RTX
RTX
20mcg dose group performed best among all dose groups, including placebo (
lidocaine
only) and approved intra-articular corticosteroid (
Zilretta
) on short-term and prolonged
pain
relief measures (SPID, KOOS, WOMAC). Summary of Pain Intensity Difference (SPID) A chart accompanying this announcement is available at Although at many time points,
RTX
20mcg was statistically significant as compared to the approved drug (
Zilretta
®) in this indication active control, we note that the study was not powered to demonstrate statistical significance for all end points listed (primary, secondary), with only 120 patients enrolled across 5
RTX
dose groups and early terminations due to the Company’s previously announced bankruptcy proceedings. Despite the limitations of the study (small number of patients per group, high variability of placebo responders due to intra-articular use of 10ml
lidocaine
and
capsaicin
cream for blinding per FDA request), the results = demonstrate that
RTX
RTX 20mcg
is an effective
pain
treatment for longer durations (up to one year), with better score improvements at week 26 and 52 than the current standard of care (active steroid injection.
Zilretta
) up to and past week 26. A chart accompanying this announcement is available at A higher proportion of patients responded to treatment with
RTX
RTX
20mcg than any other treatment group, including
Zilretta
. Reduction in
pain
was also more pronounced with
RTX
RTX 20mcg
than with any other treatment group, including placebo and active control. A table accompanying this announcement is available at Durability of treatment was nearly twice as long for
RTX
RTX
20mcg than active steroid control (mean time to return to 10% of baseline of 19 weeks for
RTX
RTX
versus 10 weeks for
Zilretta
). In conclusion, we report that the phase 2a OAK study for
RTX
has met all the primary and secondary objectives for the study. The Phase 2a results were consistent with the prior safety pro the drug from the previously completed Phase 1 study and has allowed for the potential determination of a therapeutically effective dose for further phase 2 pivotal or phase 3 studies, which is expected to be powered with a sufficient number of patients to provide significantly different results from the controls. “We are extremely pleased with the outcome of this study. The clinical trial confirmed the potential of
resiniferatoxin (RTX)
RTX
) in helping patients with moderate to severe
osteoarthritis pain
for at least 6 months, if not longer. No other drug on the market can provide this much
pain
relief, for this long a period, from a single administration,” stated Dr. Henry Ji, Chairman and Chief Executive Officer. About
RTX
A thousand times “hotter” than pure
capsaicin
(16 billion Scoville units versus 16 million), and with a high affinity for afferent sensory pain nerves,
RTX
RTX
binds to TRPV1 receptors present and selectively ablates the nerve endings responsible for
pain
signals experienced by patients1. Delivered peripherally (into the joint space) the transient nerve ending ablation effect can have profound clinical benefits lasting for months to years (as shown in canine studies2). The first
arthritis pain
clinical trial in humans was completed in 2021. That study was a multicenter, placebo-controlled Phase 1b/2 study to assess the safety and define the maximally tolerated dose of
RTX
RTX
administered in the knee joint in patients with moderate to severe
pain
associated with
osteoarthritis of the knee
. The study was a dose-escalation trial in which cohorts of patients receive increasing doses of
RTX
RTX
until the maximum tolerated dose (MTD) was achieved. The primary objective of the study was to evaluate the safety of
RTX
RTX
and identify the recommended Phase 3 dose. The secondary objective was to assess the preliminary efficacy of
RTX
RTX
measured by assessing changes in the intensity of
pain
using the A1 score from the WOMAC, a widely used proprietary validated
pain
questionnaire. The second
arthritis pain
phase 2a clinical trial in humans completed enrollment in September 2022. The results of study are expected to confirm the phase 3 doses and demonstrate long-term effectiveness of
RTX
RTX
in controlling
osteoarthritis pain
when compared to placebo or active steroid intra-articular injections.
Sorrento
Sorrento
continues to progress as planned on all clinical fronts of the
RTX
program, including exploring additional orphan indications with breakthrough potential.
RTX
RTX
is an extremely potent compound used therapeutically in very small concentrations. It is very challenging to formulate and keep stable long-term when made in large quantities.
Sorrento
has been working on process optimization of
RTX
manufacturing for several years and continues to advance the validation and scale up, with the expectation to have final validated batches completed by the end of 2023. Ensuring the company can meet market demands from API to finished product once phase 3 trials have been completed has been identified as a critical priority, which
Sorrento
is currently addressing. The
osteoarthritis
treatment market and in particular the
Knee Osteoarthritis
and injectable markets have historically seen healthy growth and are expected to continue the trend as populations age and present excessive weight. More information on this completed trial can be found at (NCT03542838). 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 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 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
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
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 . 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 the expectations for
Sorrento
's and its subsidiaries' technologies and product candidates, including, but not limited to,
resiniferatoxin (RTX)
RTX
), the clinical potential of
RTX
RTX
, including the potential for
RTX
RTX
to address long-term control of
pain
associated with
osteoarthritis of the knee
,
RTX
RTX
’s potential to become a key therapeutic in the
knee osteoarthritis
and injectable markets, expected timing of initial efficacy data on
pain
relief parameters and initial topline data, the potential superiority of
RTX
over any active comparators, timing for conducting an end of phase 2 meeting with the FDA and concurrent phase 3 clinical trials, completion and submission of a request to proceed with any Phase 3 trial for
RTX
, the possibility of proceeding to a Phase 3 trial, the possibility of obtaining accelerated international registration for
RTX
, any potential additional orphan indications for
RTX
with breakthrough potential and the expected timing for having final validated batches for
RTX
. 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 seeking regulatory approval for
RTX
; 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; risks relating to the voluntary proceedings under Chapter 11 in the Bankruptcy Court (the “Chapter 11 Cases”),
Sorrento
’s ability to continue operating in the ordinary course while the Chapter 11 Cases are pending, the timing and outcome of the Chapter 11 Cases,
Sorrento
’s ability to obtain timely approval by the Bankruptcy Court of the motions filed in the Chapter 11 Cases, employee attrition and
Sorrento
’s ability to retain senior management and other key personnel due to the distractions and uncertainties of the Chapter 11 Cases,
Sorrento
’s ability to maintain relationships with suppliers, customers, employees and other third parties and regulatory authorities as a result of the Chapter 11 Cases, the Bankruptcy Court’s rulings in the Chapter 11 Cases, the length of time that
Sorrento
will operate under Chapter 11 protection and the continued availability to
Sorrento
of operating capital during the pendency of the Chapter 11 Cases, risks associated with any third party motions in the Chapter 11 Cases, increased administrative and legal costs related to the Chapter 11 process, exposure to potential litigation and inherent risks involved in a bankruptcy process, the potential adverse effects of the Chapter 11 Cases on
Sorrento
’s liquidity or results of operations, or
Sorrento
’s ability to timely periodic reports or meet periodic reporting requirements with the SEC; 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, 2022, 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 Alexis Nahama, DVM (Head of
RTX
Program) Email: mediarelations@sorrentotherapeutics.com
Sorrento
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
™ 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. ©2023
Sorrento Therapeutics, Inc.
All Rights Reserved. ________________________ 1 2
Sorrento Therapeutics
(Ark Animal Health) internal data (on file) Table 1 Table 1 Chart 1 Chart 1 Chart 2 Chart 2 Table 2 Table 2
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机构
Sorrento Therapeutics, Inc.
RTX Healthcare A/S
Semnur Pharmaceuticals, Inc.
[+1]
适应症
膝关节炎
疼痛
常染色体显性视神经萎缩
[+10]
靶点
TRPV1
药物
树胶脂毒素
利多卡因
曲安奈德
[+15]
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