Sorrento Therapeutics has secured the Brazilian health regulatory agency ANVISA authorisation to commence a Phase IIa clinical trial of COVI-MSC for treating ‘long haul’ pulmonary compromise following Covid-19 infection, or long Covid.
COVI-MSC is a human allogeneic adipose-derived mesenchymal stromal cells (MSC) product candidate.
The multicentre, randomised, placebo-controlled trial will analyse the safety and efficacy of up to three intravenous doses of COVI-MSC given on alternate days versus placebo, along with standard of care.
It will have 60 individuals who have been experiencing respiratory issues as a result of a SARS-CoV-2 infection a minimum of three months before enrolment into the trial.
Improvement in the six-Minute Walk Distance (6MWD) test at day 60 following treatment, will be the primary outcome measure of the trial.
Sorrento anticipates this enrolment pace due to the previous broad Covid-19 burden in Brazil; its collaboration with domestic clinical research organisation Synova Health; and present associations with quality medical centres in the country.
The alliance with Synova Health makes use of quality study centres as well as a dozen centres that have previously taken part in other acute Covid-19 trials of Abivertinib and MSC with Sorrento.
Sorrento Therapeutics chairman and CEO 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 II 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.”
In July last year, the company dosed participants in a Phase II trial of its intranasal drug, COVIDROPS, to treat Covid-19 in the outpatient setting in the UK.