Sorrento Announces Phase 2 Abivertinib Clinical Studies Have Completed Patient Enrollment in USA and Brazil with Top-Line Clinical Data Expected End of 3Q21
- Phase 2 US clinical trial of Abivertinib randomized last patient (#96) on 4/07/2021.
- Phase 2 Brazilian clinical trial of Abivertinib randomized last patient (#400) on 06/20/2021.
- Studies are complementary and address both dose duration and disease stage variations.
- Data from both studies is expected to be available for review by the end of 3Q21.
|BR Protocol Design||US Protocol Design|
|Mild, Moderate and Severe COVID-19 patients||Severe COVID-19 patients|
|Any hospitalized patient||ICU non-ventilated|
|N=400 randomized 3:1 (Abivertinib to placebo)||N=96 randomized 1:1 (Abivertinib to placebo)|
|100 mg QD x 7 days regardless of discharge day||100 mg QD x 14 days or hospital discharge, whichever is sooner|
|Duration 45 days||Duration 94 days|
% alive and discharged from hospital by Week 4
% alive and free of respiratory failure at Week 4
Closing enrollment for both studies is a significant milestone. In two to three months the company expects to be able to disclose top-line data. If positive, the results of the two parallel and independently run clinical trials should provide valuable insights into the ability of Abivertinib to help patients with pulmonary distress associated with cytokine storm induced by COVID-19.
“We are very satisfied with the progress made by our team and we are eager to review the results of these two parallel trials,” stated Dr.
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™”). 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 IB 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.