Sorrento Therapeutics Inc (NASDAQ: SRNE) reported initial success in Rheumatoid patients by administering Enbrel using its Sofusa Lymphatic Delivery System in phase 1b POC (Proof of concept) trial.
Improper functioning of the immune system is responsible for various autoimmune diseases like Psoriasis, Multiple Sclerosis, and Rheumatoid Arthritis, and cancer.
Sorrento developed Sofusa Lymphatic Delivery System that comprises microneedles. The device helps to open the tight junctions in patients’ skin and ensures transcellular and paracellular transport across the epidermis and into the lymphatic system.
Improves lymph node concentrations
In the preclinical trial, the microfluidics system and microneedles showed consistency and significant improvement in delivering a drug to the targeted lymph nodes compared to the IV (Intravenous) and SC (subcutaneous) injections. Improved lymph node concentrations are observed beyond 72 hours after administering the drug using Sofusa (just after 1 hour).
Sorrento concentrates its clinical study STI-SOFUSA-1003 on patients with severe to moderate RA (Rheumatoid Arthritis). It includes patients, who failed to develop and maintain adequate response to the drug – Enbrel administered using SC injections, in the clinical study.
SVP (Sofusa Lymphatic Drug Delivery Systems) of Sorrento, Brian Cooley, said several patients with improper autoimmune conditions usually benefit from biologic therapy. However, some patients fail to develop sufficient response in this therapy.
Enbrel received approval to treat patients with Rheumatoid Arthritis. The company plans to evaluate the efficacy and safety of the drug in non-responsive Rheumatoid Arthritis using its Sofusa to deliver into the lymphatics.
The non-responsive Rheumatoid Arthritis patients will be administered 50 mg of Enbrel every week for 12 weeks before enrolling in the clinical study. In the trial, the patients will be administered 25 mg of Enbrel using Sofusa for 4 weeks. After that dosage will be increased to 50 mg Enbrel for an escalation study if required. It will deliver Enbrel using Sofusa every week for 12 weeks.
In the clinical trial, Sorrento will observe the primary endpoint of tolerability and safety of Sofusa in administering Enbrel weekly once in patients with Rheumatoid Arthritis. Sorrento will also assess the pilot efficacy with the help of composite scores like the DAS28 score for the disease activity. In the pilot efficacy trial, 28 joints will be examined in each session.
Sorrento also evaluates lymphatic pumping rates through NIRF (near-infrared fluorescence) imaging as an exploratory endpoint.