Direct Biologics has reported positive safety and efficacy results from its expanded access programme of ExoFlo to treat hospitalised adult Covid-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS).
The results showed that no serious adverse events were reported related to ExoFlo.
A Grade 1 adverse event associated with ExoFlo, hyperpigmentation at the infusion site, was reported.
The findings demonstrated no infusion reactions, thereby supporting the favourable safety profile of ExoFlo.
It was also found that the overall 60-day mortality rate was less in patients aged below 65 years compared to those aged between 65 and 85 years.
In addition, patients below 65 years of age were discharged from the hospital sooner and had more ventilator-free days than 65–85-year-old patients.
In January 2021, the company commenced the multicentre expanded access programme in the US to evaluate intravenous ExoFlo in the targeted patients.
The programme also included patients with respiratory failure who could not participate in Direct Biologics’ Phase ll or Phase lll trials.
So far, 103 patients have been enrolled and received treatment in the programme.
Patients were treated with a 60-minute infusion of ExoFlo-15ml diluted to 100ml in normal saline up to three times within a week.
They were also treated with simultaneous standard-of-care for severe-to-critical Covid-19.
Direct Biologics CEO Mark Adams said: “We believe ExoFlo is the first regenerative medicine product candidate to demonstrate this level of tolerability in patients who are critically ill with Covid-19 associated ARDS.
“The potential for ExoFlo to treat critically ill patients with Covid-19 associated pulmonary complications represents a powerful advancement in our efforts to combat this disease.”
The company is currently investigating ExoFlo in the Phase lll EXTINGUISH ARDS trial for treating hospitalised patients with moderate-to-severe ARDS from any underlying aetiology.