In an April 21 research note, Dawson James Securities analyst Jason Kolbert reported that Sorrento Therapeutics Inc. (SRNE:NASDAQ) completed its Phase 1b MSC-COV-101 trial of COVI-MSC, allogeneic adipose-derived mesenchymal stem cells, as a treatment for COVID-19-induced acute respiratory failure (ARD) and acute respiratory distress syndrome (ARDS).
Kolbert highlighted that the study was successful in that it showed the safety of intravenous infusion of COVI-MSCs in patients with ARD or ARDS resulting from COVID-19.
The analyst explained that the trial comprised 10 inpatients, 8 men and 2 women. Before treatment, all had obesity and other comorbidities and needed supplemental oxygen. Also, they all had an abnormal ratio of arterial oxygen partial pressure to fractional inspired oxygen, ranging from 135 to 256, where normal is above 400.
All of the study participants were administered COVI-MSCs in up to three infusions on an every-other-day schedule. The 10 patients were discharged from the hospital within 3 days of their last infusion and were subsequently followed for 28 days.
As an example of preliminary efficacy, Kolbert relayed that the final patient to be enrolled had been treated unsuccessfully for nearly two weeks prior to receiving COVI-MSCs. The patient was discharged after a second infusion, with room-air oxygen-saturation levels in the high 90s. In follow-up days later, the patient was still doing well.
The next step for Sorrento and its COVI-MSCs, Kolbert noted, is a pivotal, multisite (in the U.S. and Brazil), placebo-controlled study to be done in support of the company's emergency use authorization application. Once all Phase 1b data are available, the biopharma, with guidance from the U.S. Food and Drug Administration, will plan the subsequent trial.
Dawson James has a Buy rating and a $19 per share price target on Sorrento Therapeutics, the current share price of which is about $8.63.
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Disclosures for Dawson James Securities, Sorrento Therapeutics, April 21, 2021
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