Brazilian Health Regulatory Agency (ANVISA) Authorizes Sorrento Phase 2 Pivotal Clinical Trial of COVI-MSC in Hospitalized COVID-19 Patients With Acute Respiratory Distress Syndrome
Sorrento Therapeutics, Inc. announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed with a Phase 2 Pivotal clinical trial of COVI-MSC™, an injectable infusion of mesenchymal stem cells, for the treatment of hospitalized COVID-19 patients suffering from ARDS.
The Brazil study is a Phase 2 Pivotal, multi-center, randomized, controlled study to evaluate the safety and efficacy of three infusions of COVI-MSC™, administered every other day, to hospitalized patients experiencing moderate or severe COVID-19 with ARDS. The study is expected to enroll 100 patients (33 placebo and 67 treated patients) in three months from the date of first enrollment. Sorrento expects this projected pace of enrollment due to the extensive COVID-19 disease burden in Brazil, Sorrento’s partnership with a leading local clinical research organization (Synova Health), and existing relationships with high quality medical centers throughout the country. The current partnership with Synova Health leverages high quality clinical trial sites in addition to a dozen centers already enrolling COVID-19 patients for another Sorrento Phase 2 clinical trial (Abivertinib). Additional studies are also being discussed for early clearance in parallel or immediately following this study. Priority access to multiple trials is being given to Brazilian patients following the rapid and openly collaborative interactions Sorrento has been able to establish with ANVISA regulators.
“We are very satisfied with the progress made in Brazil so far, and we have developed strong local relationships in support of multiple studies,” stated Dr. Henry Ji, Chairman and CEO of Sorrento. “By focusing on the geographies most impacted by COVID-19, we are able to implement synergistic programs to answer safety and efficacy questions related to our product candidates while helping patients where the disease has been spreading the most. We expect this next Phase 2 Pivotal study to confirm the clinical benefits initially observed in our recently completed open label Phase 1b study. If confirmed, we are ready to establish a plan for development and manufacturing commitments that are required by ANVISA to take the product candidate from clinical trials to emergency use authorization (EUA) approval, including generating the data needed to support making the drug accessible prior to any full registration.”
The study is referenced with ANVISA (Brazilian authority) under Process nº 25351.986743/2021-44, COMUNICADO ESPECIAL (CE) Nº 0004/21 – GSTCO/DIRE1/Anvisa.