REDWOOD CITY, Calif., July 25, 2022 (GLOBE NEWSWIRE) — Asvattha Therapeutics (“Asvattha”), a clinical-stage company developing novel hydroxyl dendrimer therapeutics, today announced the publication of the results of a Phase 2a clinical trial demonstrating significant reduction of 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 document entitled “Dendrimer nanotherapy for severe COVID-19 attenuates markers of inflammation and neurological damage and improves outcomes in phase 2a clinical trial,” was published in a peer-reviewed scientific journal Scientific Translational Medicine.
The Phase 2a (PRANA) study, a multicenter, double-blind, placebo-controlled, single-dose-escalation study, evaluated the safety, tolerability, and preliminary efficacy of OP-101 dosed intravenously at 2 mg/kg, 4 mg/kg, and 8 mg/kg in three cohorts compared with a single intravenous dose of placebo in patients with severe COVID-19.
Key findings published in Scientific Translational Medicine include:
- OP-101 was shown to improve dose-matched survival (2 mg/kg: 67%; 4 mg/kg: 100%; 8 mg/kg: 80%) versus placebo (43%).
- The risk for the combined outcome of mechanical ventilation or death at days 30 and 60 after treatment was 71% for placebo and 18% for the pooled OP-101 treatment arms.
- At day 60, three of seven placebo-treated patients and 14 of 17 OP-101-treated patients survived, and surviving OP-101-treated patients did not require mechanical ventilation until day 30 or 60- th day.
- Treatment with OP-101 was associated with an attenuation of the neuronal damage markers NfL and GFAP that persisted until day 30 of the study.
- OP-101 dosed at 4 mg/kg treatment significantly reduced the hyperinflammatory markers TNF-α, IL-6, and IL-8.
- No drug-related adverse reactions were reported.
“We are extremely pleased with these positive results, which support OP-101’s potential to significantly improve clinical outcomes and survival in patients with severe COVID-19,” said Jeffrey Cleland, MD, chairman and CEO of Ashvattha Therapeutics. “These data also confirm the ability of our hydroxyl dendrimer therapies to cross tissue barriers, including the blood-brain barrier, selectively targeting areas of inflammation with an excellent safety profile that may benefit patients with other diseases characterized by with inflammation. We hope we can see similar results in patients suffering from Long COVID.”
This article was published in its entirety in Volume 14, Issue Number 654 of Scientific Translational Medicine and can be accessed here.
OP-101 is an N-acetyl cysteine (NAC) HDT that selectively targets reactive macrophages and microglia that are responsible for hyperinflammation, lung injury, and multiorgan failure caused by viral or bacterial infections, including COVID-19.
About Asvattha Therapeutics
Asvattha Therapeutics is a clinical-stage biotechnology 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 of Johns Hopkins University. HDs chemically conjugated to disease-modifying drugs create novel proprietary HD therapeutics (HDTs) that selectively target reactive inflammatory cells in diseased tissue with localized, sustained effects. Asvattha has initiated multiple programs with HDTs focused on neurology, ocular neovascular diseases including neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME), and hyperinflammation in diseases. For more information visit: www.avttx.com.
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