Ashvattha Therapeutics has reported data from the Phase IIa PRANA clinical trial where OP-101 boosted clinical outcomes in severe Covid-19 patients.
The multicentre, placebo-controlled, double-blind, single-sequential, ascending dose trial analysed the safety, tolerability and initial efficacy of intravenous OP-101 versus placebo in severe Covid-19 patients.
In the trial, 2mg/kg, 4mg/kg and 8mg/kg doses of OP-101 were analysed in three cohorts versus a single intravenous dose of placebo.
According to the trial findings, OP-101 demonstrated to boost survival, in line with a rise in dosage.
A 2mg/kg dose of the HDT showed 67% improved survival while 4mg/kg and 8mg/kg demonstrated a 100% and 80% improvement, respectively, compared to 43% on administering placebo.
At 30 and 60 days, the risk for the composite outcome of mechanical ventilation or mortality was 18% in the combined OP-101 treatment groups versus 71% in the placebo arm.
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Three out of seven placebo-treated subjects and 14 of 17 who received OP-101 were alive at 60 days while those subjects in the OP-101 arms did not need mechanical ventilation.
OP-101 was linked to attenuating neuronal injury markers NfL and GFAP, which lasted until day 30 of the trial.
Furthermore, 4mg/kg of OP-101 substantially lowered hyperinflammation markers TNF-α, IL-6 and IL-8.
No cases of drug-associated adverse events were observed in the trial.
A hydroxyl dendrimer therapeutic (HDT) with N-acetyl cysteine (NAC), OP-101 is administered intravenously.
It acts on reactive macrophages and microglia, which cause hyperinflammation, injury to the lungs and multi-organ failure due to viral or bacterial infections, including Covid-19.
Ashvattha Therapeutics chairman and CEO Jeffrey Clelland said: “We are incredibly pleased with these positive results that support the potential of OP-101 to significantly improve clinical outcomes and survival for patients with severe Covid-19.
“This data also validates the ability of our hydroxyl dendrimer therapies to cross tissue barriers, including blood-brain barriers, selectively targeting areas of inflammation with an excellent safety profile, which could benefit patients with other diseases characterised by inflammation.”