Subscribe to our newsletter
It will be conducted through researchers from major U.S. university medical centers.In addition to Johns Hopkins Hospital, Emory University, Loma Linda University Health and the University of Texas Health Science Center at Houston (UTHealth).
Severe COVID-19 is characterized by excessive activation of macrophages, immune cells guilty of hyperinflamation, which can lead to life-threatening complications.aim and prevent all pro-inflammatory pathways and repair macrophages to a general anti-inflammatory state.
“Severe COVID-19 patients can get worse because their immune reaction to SARS-CoV-2 is overdone. This causes hyperinflammation, tissue damage, and a cytokine typhoon, which can lead to lung damage,” said Ishan Mehta, MD, a researcher. on the PRANA exam at Emory University School of Medicine. “OP-101 is a promising remedy for this patient organization due to its ability to selectively target reactive macrophages in the lungs. Patients hospitalized for severe COVID-19 desperately need new remedies that can speed their recovery, shorten the duration of a serious illness and potentially avoid prolonged hospitalization.
PRANA (OP-101 to ArRest HyperinflAmmatioN in COVID-19 PAtients) is a randomized, double-blind, placebo-controlled Phase 2 clinical exam that compares OP-101 in patients with COVID-19 severe as explained through the World Health Organization (WHO) .ordinal score.The exam will recruit approximately 2 four patients who, in addition to the care treatment, will be randomly assigned for a single intravenous (IV) infusion of OP-101 (2 mg/kg, four mg/kg or 8 mg/kg) or a placebo.The main criterion is protection and tolerability.Secondary endpoints come with the effectiveness measured through fever resolution, progressive oxygenation, clinic or hospital discharge, number of days without a ventilator, number of days in intensive care sets (ICU), hospitalizations and deaths, among other measures.The test will also compare the effect of OP-101 on reducing the blood grades of pro-inflammatory biomarkers (p.e.g. C-reactive protein [PCR], ferritin and interleukin-6 [IL-6]) after a single dose of OP-101Array
“With the five clinical trial sites in operation, we look forward to completing the recruitment of COVID-19 patients with very poor health who receive oxygen and fans in our Phase 2 study.As the pandemic continues to spread in the United States and around the world, new approaches are urgently needed that can lessen the devastating effect of hyperinflamation in critically ill hospitalized patients,” said Jeffrey Cleland, Ph.D., president and CEO of Ashvattha Therapeutics and ceo of Orpheris.”We believe there is a strong clinical justification for the clinical progression of OP-101 to treat patients with severe COVID-19 due to its unique mechanism of action, which has been demonstrated in animal models to prevent multiple pathways that cause hyperinflamation, potentially cutting or eliminating lung inflammation and multi-organ failure.”
Initial knowledge of the Phase 2 proof-of-concept exam is expected to be published in the fourth quarter of 2020.An extension of a double-blind placebo-controlled COVID-19 trial discussed with the US Food and Drug Administration has been a case-off.FDA, which is expected to arrive with up to 20 sites after comparing the effects of the existing stage.
About OP-101
OP-101, an experimental compound created through the mixture of N-acetylcytein with hydroxyl dendrimer, is the only clinical cure with the ability to close several pathways that cause hyperinflammaation.OP-101 selectively targets reactive macrophages guilty of hyperinflamation, lung and multiorgan damage caused through viral or bacterial infections.Through this unique targeted mechanism of action, OP-101 increases the ability to effectively prevent hyperinflamation while potentially avoiding side effects and non-specific immune suppression.
OP-101 has been shown to prevent hyperinflamation by normalizing reactive macrophages, cutting off the pro-inflammatory cytokine typhoon and cutting oxidative tension after a single dose in several animal inflammation models.Once the macrophage, OP-101 inhibits IƘƘβ and NFƘβ, blocking the expression of pro-inflammatory cytokines such as IL-6 and IL-1, and inhibits the JAK/STAT/MAPK pathway.
Results of a phase 1 test of a single intravenous dose of OP-101 (20 or 40 mg/kg) in healthy volunteers showed that it was well tolerated based on an evaluation of clinical and laboratory adverse events.The single subcutaneous dose (SC) of OP-101 (4 or 8 mg/kg) in healthy volunteers showed that it was tolerated well, with only brief minor reactions at the injection site and without other adverse events.Preclinical studies have shown that OP-101 persists for up to a month at the site of inflammation and is eliminated systemically in two days, potentially allowing SC management once a month.
Source: Company press release
Blade Therapeutics Updates Recruitment Progress for BLD-2660 Covid-19 Pneumonia Study
Enter your email so we can contact you.
© PBR 2020. Part of Progressive Trade Media Ltd.