Sorrento Publishes Positive Initial Results of SOFUSA® Lymphatic Drug Delivery System in a Phase 1b Rheumatoid Arthritis Study Using Enbrel
- Rheumatoid Arthritis (RA) is one of many chronic autoimmune conditions affecting over 20 million people in
the United States( NIH, 2017).
- Sofusa is a revolutionary technology which delivers biologic therapies through the skin and into the lymphatic system.
- Current biologic treatments for RA are delivered by either subcutaneous (SC) injection or intravenous (IV) infusion and response rates for treatment with biologic drugs for RA (e.g., etanercept) plus methotrexate are approximately 35-40%.
- The first patient treated with Sofusa with Enbrel achieved a dramatic improvement in disease activity in just 12 weeks receiving only 50% of the Enbrel subcutaneous dose weekly:
- Disease activity as measured by DAS28-ESR decreased 34.1% from 4.58 at Baseline to 3.02 at Week 12 demonstrating a change from moderate to low disease activity. The lowest DAS28-ESR achieved was 2.10 at Week 10 after 10 weekly doses which corresponds to a disease activity level of remission.
- The number of tender joints decreased from Week 0 to Week 12 by 70.6% (full 68-Joint Count) and 90.9% (28-Joint Count).
The development of tumor necrosis factor (TNF) inhibitors has greatly improved the treatment of RA, but many patients either do not respond or relapse after therapy. TNF is produced by a variety of immune cells that reside within lymph nodes and the lymphatic system. A Phase 1b open label study is examining the changes in RA disease progression by administering Enbrel, a TNF inhibitor, to the lymphatic system and draining lymph nodes using the SOFUSA device. The first patient to participate in this ongoing study was a 43-year-old female who had an inadequate response to Enbrel after 11 months of once weekly 50mg Enbrel SC injections.
After 12 weeks of receiving SOFUSA with Enbrel at 25 mg weekly, disease activity as measured by DAS28-ESR decreased 34.1% from 4.58 at Baseline to 3.02 at Week 12 demonstrating a change from moderate to low disease activity. Similarly, DAS28-CRP decreased 37.5% from 4.99 at Baseline to 3.12 at Week 12 demonstrating a change from high disease activity to moderate disease activity. The lowest DAS28-ESR achieved was 2.10 at Week 10 after 10 weekly doses which corresponds to a disease activity level of remission. A study extension has been IRB approved to evaluate the potential for further dose reductions in patients who respond well to 25 mg weekly dosing.
Joint counts were performed every 2 weeks and a consistent decrease in the number of tender and swollen joints was recorded for the entire 12-week dosing period. The number of tender joints decreased from Week 0 to Week 12 by 70.6% (full 68-Joint Count) and 90.9% (28-Joint Count). Similarly, the number of swollen joints decreased from Week 0 to Week 12 by 44.4% (full 66-Joint Count) and 28.6% (28-Joint Count).
“Our hypothesis for this study was that delivering Enbrel directly into the lymphatics would improve clinical response. While this is only the first patient, the improvement is quite remarkable and suggests that delivering therapy directly into the lymphatics may be one of the factors associated with improved response to biologic therapies delivered systemically. It was also quite interesting to see the correlation between lymphatic flow and clinical response. We are looking forward to enrolling more patients in this study” –
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 (“ADC”), and clinical stage oncolytic virus (“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 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 post-herpetic neuralgia. RTX has completed a Phase 1b trial for intractable pain associated with cancer and a Phase 1b trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on
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Source: Sorrento Therapeutics, Inc.