Tetra Bio-Pharma Inc. TBPMF TBP JAM revealed positive preclinical results from live SARS-CoV-2 virus infection studies as well as a septic lung model, carried out by independent researchers.
These studies explored the potential of ARDS-003 to increase survival metrics following SARS-CoV-2 infection in the humanized ACE2 mouse model. Secondary outcomes evaluated ARDS-003 against an antiviral drug, a clinical standard of care therapeutic used for patients with COVID, in SARS-CoV-2 infected animals. Results indicate that compared to placebo, ARDS-003 dose dependently reduced signs of morbidity and mortality, including respiratory distress. ARDS-003 also outperformed the antiviral drug in reducing multiple proinflammatory mediators involved in hyperinflammation and immune system dysfunction following viral infection.
Using a recent septic lung model, the administration of ARDS-003 produced a significant reduction of systemic cytokine/chemokine release. In addition, lung histology was improved, peripheral immune hyper activation was reduced, and there was an improvement in capillary perfusion in lung tissue compared to controls. An additional study evaluated in vitro viral infectivity and demonstrated dose dependent inhibition of viral replication.
Guy Chamberland, CEO and CRO at Tetra stated “ARDS-003 is a clinical stage asset that has a huge potential as it is focused on developing novel treatments for unmet medical needs, such as lung inflammation, viral encephalitis, and brain inflammation conditions.”
ARDS-003 Oral Formulation
Further to the ARDS-003 injection formulation, Tetra’s research team has developed an oral formulation using its proprietary technology for an immediate release administration that can be administered for longer term care in an outpatient setting. ARDS-003 has the potential to reduce the cytokine storm associated with CAR T immunotherapy complications and has been shown to have synergistic antiviral effects in several viral in vivo infection models.
Dr. Chamberland added “ARDS-003, for example, could be used as an adjunct to Paxlovid or other antivirals to help reduce the morbidities associated with prolonged infection by SARS-CoV-2 and other viruses. In the case of COVID, the treatment period with ARDS-003 could be extended to continue to improve clinical outcome and prevent the rebound effect observed in immunocompromised patients receiving existing antivirals.”
ARDS-003 is a novel first in human drug product containing the active pharmaceutical agent, Onternabez, a potent and selective full agonist of the type 2 cannabinoid receptor, an important immunomodulatory target. ARDS-003 is positioned to modulate acute systemic inflammation and prevent sepsis, ARDS, and organ damage – ARDS represents the severe end of lung dysfunction resulting from systemic inflammation secondary to infectious or non-infectious clinical insult. While the clinical profile of ARDS arising from viral or bacterial sepsis can vary, hyperinflammation involving a dysfunctional immune response is a common mediator of lung damage. Tetra’s preclinical studies have demonstrated that ARDS-003 decreases this hyperinflammatory response and slows disease progression.
Photo by Louis Reed on Unsplash
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Image and article originally from www.benzinga.com. Read the original article here.