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- Phase 2 study of RTX for OA pain continues after FDA approval.
- Phase 1b data demonstrated RTX safety for a single intra-articular administration with no dose limiting toxicity (DLT) at all doses tested up to 30 µg.
- Phase 1b data showed significant efficacy supporting RTX as an ideal candidate for long-term control of refractory OA pain: significant pain relief in patients with advanced OA disease (Kellgren-Lawrence Grade 3/4) and sustained pain relief for 6 months .
- Sorrento believes RTX has the potential to become a major therapeutic in a market segment that is expected to continue growing and exceed $ 10 billion by 20251
SAN DIEGO, July 06, 2021 (GLOBE NEWSWIRE) – Sorrento Therapeutics, Inc. (NASDAQ: SRNE, “Sorrento”) announced today that it has received FDA approval for the continuation of a Phase 2 clinical trial of RTX to treat moderate to severe knee pain osteoarthritis (OAC).
The Phase 2 study, a multicenter, double-blind, placebo and actively controlled study, will assess the efficacy and safety of multiple dose groups of RTX for pain management in patients with moderate to severe osteoarthritis of knee pain (OAK) (clinicaltrials.gov: NCT04885972). Given the previously proven durability of OA pain relief on RTX, Sorrento decided to add an active comparator (injectable corticosteroid) to the current study protocol. Superiority data that RTX may generate over a widely used approved drug could be useful for expedited international (Europe) registrations and is required for pricing purposes in Europe.
This Phase 2 study follows the analysis of the significant observations from the Phase 1b study (NCT03542838) results of RTX Day 84 patient data that completed one year after the last patient visit in February 2021. This Phase 1b study was a double-blind, placebo-controlled, dose-escalating study in 94 patients and included an open expansion cohort to assess the long-term safety and preliminary efficacy of a single intra-articular dose of RTX or saline (as a placebo group) for the treatment of moderate to severe pain due to osteoarthritis of the knee. The magnitude of the difference in treatment effect (RTX vs. saline control) after 12 weeks exceeded what is traditionally considered sufficient to support regulatory approval, based on a reduction of more than 2 points on the WOMAC A1 scale of 10 Points “Pain when walking on a flat surface”. “Compared to placebo. RTX met this requirement in this study.
The Phase 1b study was designed to follow patients through day 84 (primary endpoint). Patients also had the opportunity to be followed up for up to a year. Pain relief appeared to be very consistent among patients who responded to initial treatment, with a large proportion of patients followed through day 84 showing pain relief that persisted beyond all time points assessed during the one year follow-up period were. Rapid relief (starting within days, optimal pain relief within weeks) and persistence of effects (over 84 days) confirm the clinical potential of the RTX drug for long-term control of pain in osteoarthritis of the knee.
RTX’s clinical development program continues, with Phase 2 and 3 clinical trials planned in larger patient populations. The first phase 2 study will focus on determining the recommended phase 3 dose.
_______________1 Osteoarthritis Market Size, Share, Value, and Competitive Landscape 2021-2026 – MarketWatch
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 binds to existing TRPV1 receptors and selectively removes the nerve endings responsible for patient pain signals2. Administered peripherally (into the joint space), the transient ablation effect of the nerve ending can have profound clinical benefits lasting months to years (as shown in dog studies3).
PTVA-OA-001 was a phase Ib, multicenter, placebo-controlled study designed to evaluate safety and define the maximum tolerated dose of RTX to be administered in the knee joint in patients with moderate to severe pain associated with osteoarthritis of the knee. The study was a dose escalation study in which cohorts of patients received incremental doses of RTX until the maximum tolerated dose (MTD) was reached. The main objective of the study was to evaluate the safety of RTX and determine the recommended phase 3 dose. The secondary objective was to evaluate the preliminary efficacy of RTX as measured by assessing changes in pain intensity using the A1 score of WOMAC, a widely used proprietary validated pain questionnaire.
The osteoarthritis treatment market, and specifically the knee osteoarthritis and injectable injections market, has seen healthy growth in the past and is expected to continue the trend as the population ages and becomes excessively weighty. Multiple sources estimate the market to be around 50 million patients and $ 7 billion in 2020.
For more information on this completed study, please visit www.clinicaltrials.gov (NCT03542838).
_______________2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC398431/3 Sorrento Therapeutics (Ark Animal Health) internal data (in file)
About Sorrento Therapeutics, Inc.
Sorrento is an antibody-focused, clinical-stage biopharmaceutical company developing new therapies to treat cancer and COVID-19. Sorrento’s multimodal, multi-pronged approach to fighting cancer is enabled by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB ™ Library”), clinical-stage immunocellular therapies (“CAR-T”, “DAR-T ™”), antibody-drug conjugates (“ADCs”) and oncolytic viruses in the clinical stage (“Seprehvir ™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIGUARD ™, COVI-AMG ™, COVISHIELD ™, Gene-MAb ™, COVI-MSC ™ and COVIDROPS ™; and diagnostic test solutions, including COVITRACK ™, COVISTIX ™, and COVITRACE ™.
Sorrento’s commitment to life-enhancing therapies for patients is also reflected in our efforts to provide a world-class (TRPV1 agonist) low molecular weight non-opioid pain reliever 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® (topical lidocaine system) post-therapeutic neuralgia. RTX has completed a Phase IB study in persistent pain-related cancer and a Phase 1 B study in osteoarthritis patients. SEMDEXA is in a pivotal phase 3 study for the treatment of lumbosacral radicular pain or sciatica. ZTlido® was approved by the FDA on February 28, 2018.
More information is available at www.sorrentotherapeutics.com.
This press release and any statements made for and during any presentation or meeting contain forward-looking statements regarding Sorrento Therapeutics, Inc., subject to and subject to the safe harbor of Section 21E of the Private Securities Litigation Reform Act of 1995 Risks and uncertainties This could mean that the actual results differ materially from those forecast. Forward-looking statements include statements about expectations of Sorrento and its subsidiaries’ technologies and product candidates, including but not limited to resiniferatoxin (RTX), the clinical potential of RTX, including the potential of RTX for long-term pain-related control Osteoarthritis of the knee, the potential of RTX to become a major therapeutic in the market for knee osteoarthritis and injectable products, time to start additional Phase 2 and 3 clinical trials for RTX, time to complete and submit an application to continue a phase 3 trial for RTX, the opportunity to move to a phase 3 trial, and the opportunity to receive accelerated international registration for RTX in Europe. 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 related to the progress, timing, costs and results of clinical trials and product development programs; Risk of difficulty or delays in obtaining regulatory approvals; Risks that clinical trial results may not achieve all or one or more of the endpoints of a clinical trial and that data generated from such trials may not support approval or approval; Risks that previous test, study and study results may not be replicated in future studies and studies; Risks in the manufacture and supply of pharmaceuticals; Risks related to using the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in executing its therapeutic antibody product candidate strategies; Risks related to the global impact of COVID-19; and other risks 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, 2020 and subsequent quarterly reports Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set out 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 press release, and we assume no obligation to update any forward-looking statements in this press release unless required by law.
Contact for media and investor relationsAlexis Nahama, DVM (SVP Corporate Development) Email: [email protected]
Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
G-MAB ™, DAR-T ™, SOFUSA ™, COVIGUARD ™, COVI-AMG ™, COVISHIELD ™, Gene-MAb ™, COVIDROPS ™, COVI-MSC ™, COVITRACK ™, COVITRACE ™ and COVISTIX ™ are trademarks of Sorrento Therapeutics , Inc.
SEMDEXA ™ is a trademark of Semnur Pharmaceuticals, Inc.
ZTlido® is a registered trademark of Scilex Pharmaceuticals Inc.
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Source: Sorrento Therapeutics, Inc.