– Data showed OP-101 delivered intravenously may have the potential to treat systemic inflammation and neuronal injury, reducing morbidity and mortality in hospitalized patients with severe COVID-19 –
REDWOOD CITY, Calif., July 25, 2022 – Ashvattha Therapeutics (“Ashvattha”), a clinical stage company developing novel hydroxyl dendrimer therapeutics, today announced the publication of the results from a Phase 2a clinical study demonstrating a significant reduction in inflammatory and neuroinflammatory markers and improved clinical outcomes with OP-101, a hydroxyl dendrimer therapeutic (HDT), delivered intravenously in patients with severe COVID-19. The paper, titled, “Dendrimer nanotherapy for severe COVID-19 attenuates inflammation and neurological injury markers and improves outcomes in a phase 2a clinical trial,” was published in the peer-reviewed scientific journal Science Translational Medicine.
The Phase 2a trial (PRANA), a multi-center, double-blind, placebo-controlled, single sequential, ascending dose study, evaluated the safety, tolerability and preliminary efficacy of OP-101 intravenously dosed at 2 mg/kg, 4 mg/kg and 8 mg/kg across three cohorts compared to a single intravenous dose of placebo in patients with severe COVID-19.
Key findings published in Science Translational Medicine include:
- OP-101 was shown to improve survival, corresponding with an increase in dosage (2 mg/kg: 67%; 4 mg/kg: 100%; 8 mg/kg: 80%) versus placebo (43%).
- Risk for the composite outcome of mechanical ventilation or death at 30 and 60 days after treatment was 71% for placebo and 18% for the pooled OP-101 treatment arms.
- At 60 days, three of seven patients given placebo and 14 of 17 OP-101 treated patients were surviving, and the surviving patients treated with OP-101 did not require mechanical ventilation by day 30 or day 60.
- Treatment with OP-101 was associated with attenuating neuronal injury markers NfL and GFAP, lasting until day 30 of the study.
- OP-101 dosed at 4 mg/kg treatment significantly decreased markers of hyperinflammation TNF-α, IL-6 and IL-8.
- No drug-related adverse events were reported.
“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,” said Jeffrey Clelland, Ph.D., Chairman & CEO of Ashvattha Therapeutics. “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 characterized by inflammation. We are hopeful that we may see similar results in patients suffering from Long COVID.”
This paper was published in its entirety in volume 14, issue number 654 of Science Translational Medicine and can be accessed here.
OP-101 is an HDT with N-acetyl cysteine (NAC) that selectively targets reactive macrophages and microglia, which are responsible for hyperinflammation, lung injury and multi-organ failure caused by viral or bacterial infections, including COVID-19.
About Ashvattha Therapeutics
Ashvattha Therapeutics is a clinical-stage biotech company developing novel hydroxyl dendrimer therapeutics (HDTs) targeting unmet medical needs in ophthalmology, neurology, inflammatory diseases and neuro-oncology. The therapies are based on hydroxyl dendrimers (HDs), a targeted platform technology exclusively licensed from our founders, Kannan Rangaramanujam and Sujatha Kannan at Johns Hopkins University. HDs chemically conjugated to disease-modifying drugs create novel proprietary HD therapeutics (HDTs) selectively targeting reactive inflammatory cells in disease tissue with localized sustained effects. Ashvattha has initiated multiple programs with HDTs focused on neurology, ocular neovascular disease including neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME), and hyperinflammation in diseases. For more information, visit: www.avttx.com.