Brazilian Health Regulatory Agency (ANVISA) Authorizes Sorrento Therapeutics' Large Phase 2 Clinical Trial of Abivertinib in Mild, Moderate and Severe COVID-19 Patients
SAN DIEGO, Oct. 14, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed with a Phase 2 clinical trial of Abivertinib in mild, moderate and severe COVID-19 patients.
The Brazil study is a Phase 2, Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19, particularly looking at the potential clinical benefits of the drug associated with its broad ability (mode of action) to reduce inflammatory cytokine storm. The dose to be tested is the same as in the U.S. Phase 2 trial, but the trial protocol in Brazil includes patients at earlier stages of the disease, with a drug administration regimen of only 7 days (versus 14 days for more advanced patients in the U.S.).
The Brazilian study is expected to rapidly enroll 400 patients. The rapid projected enrollment pace is made possible by the recent partnership established between Sorrento and a leading local clinical research organization (Synova Health) with access to high quality medical centers throughout the country.
A broad clinical development strategic alignment between Sorrento and local medical systems, including with the city of Rio de Janeiro, will also help accelerate site initiation and access to potential patients for additional Sorrento studies currently being evaluated by ANVISA.
“We are very satisfied with the progress made in Brazil so far,” stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics. “By targeting some of the geographies currently most impacted by COVID-19, we are able to implement a synergistic program to answer questions about safety and efficacy of our drug candidates in helping patients, while potentially accelerating enrollment timelines, reducing overall cost and opening up collaboration opportunities with local companies.”
The study is referenced with ANVISA (Brazilian authority) under Process nº 25351.105670/2020-14, Reference n° 3380614/20-4
Brazilian Clinical Study details can be found at:
About Sorrento Therapeutics, Inc.
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 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. ZTlido® was approved by the FDA on February 28, 2018.
For more information, visit www.sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc.
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