Sorrento Therapeutics Inc. (NASDAQ: SRNE) has received approval from the Brazilian Regulatory Agency (ANVISA) to go on with the Phase 2A placebo-controlled, randomized trial of intravenous allogeneic adipose-derived mesenchymal stromal cells for post-COVID-19 long haul pulmonary compromise treatment.
Symptoms of long haulers called “Long COVID” syndrome
According to the latest epidemiologic studies conducted in the United States and the United Kingdom, more than one out of every three COVID-19 patients may experience residual symptoms even after healing from the first phases of COVID-19 sickness. The signs in “long haulers” are sometimes referred to as “Long COVID” syndrome, and they include shortness of breath, fatigue, persistent cough, sleep disorders, “brain fog,” fevers, gastrointestinal symptoms, depression, and anxiety. They can last for months and vary in severity from mild to immobilizing. New symptoms may appear years after the illness or emerge over time in rare circumstances. While the term “Post-Acute Sequelae of a SARS-CoV-2 Infection” is currently being described, these effects can be grouped together as Post-Acute Sequelae of COVID-19 infection.
The COVI-MSC study in Brazil is a Phase two randomized, controlled, multi-center trial evaluating the efficacy and safety of around three infusions of COVI-MSC given each day to individuals with respiratory difficulty who have recovered from a SARS-CoV-2 infection for at least three months before the enrollment.
60 subjects to be enrolled in the first six months
In around 6 months from the beginning of the study, 60 individuals (in four dosage regimen groups) should be enrolled. The primary outcome measure will be improvement in the six-minute Walk Distance (6MWD) test after Day 60 following treatment.
CEO Sorrento Dr. Henry Ji said, “We are very satisfied with the progress made in Brazil so far, and we have developed very strong local relationships in support of multiple studies. We expect this next Phase 2 study to confirm the clinical benefits for long-hauler patients. Long-hauler syndrome is likely to be the next major challenge for medical systems in a post-COVID era, and we intend to be the leaders in addressing this future unmet need.”