Biotech Orpheris has been given the FDA go-ahead for a phase 2 aimed at calming the cytokine storm sometimes caused by COVID-19.
The biotech hopes its therapy can help those with the disease who are hit with a secondary complication known as a cytokine storm. This can be fatal and comes as a result of an overreaction of the body’s immune system; it’s also seen in other infections such as influenza.
With SARS-CoV-2, the virus causing the pandemic, immune cells are sent out to the lungs when the virus strikes, which causes inflammation in that area. But sometimes this can go into overdrive and cause hyperinflammation leading to injury or even death in some, and it can also hit younger patients.
Orpheris, which focuses on inflammatory, oncology and ocular diseases, now hopes to test whether its drug, OP-101, can dampen these storms after the FDA gave it a green light to test its hyperinflammation drug in a phase 2 trial.
The randomized, double-blind, placebo-controlled study is set up to assess the safety, tolerability, pharmacokinetics and efficacy of OP-101 in patients with severe COVID-19. The investigational med selectively targets reactive macrophages, aiming to lower the pro-inflammatory cytokine storm and oxidative stress.
All patients will also continue to receive standard of care in the test, the biotech added.
Although much of its work was early stage until now, it has come through a single IV dose phase 1 in normal healthy volunteers, which it says showed it was “generally well tolerated in healthy subjects based on an assessment of clinical and laboratory adverse events.”
No deaths or serious adverse events leading to discontinuation occurred during the study. The phase 2 will be the real test to see how well it can help these patients.
“We believe there is strong scientific rationale for the development of OP-101 to treat severe COVID-19 patients. The health of these patients often rapidly deteriorates due to the unchecked immune response to the virus leading to hyperinflammation and cytokine storm,” said Jeffrey Cleland, Ph.D., chairman, CEO and president at Ashvattha Therapeutics and executive chairman of Orpheris.
“The hydroxyl dendrimer component of OP-101 enables targeting to reactive macrophages, which are responsible for hyperinflammation, lung injury, and multi-organ failure caused by COVID-19. OP-101 normalizes reactive macrophages, shuts down the cytokine cascade and reduces oxidative stress to arrest hyperinflammation. We look forward to this clinical evaluation of OP-101, as there are currently no FDA approved treatment options to treat hyperinflammation in severe COVID-19 patients.”
A number of biopharmas are assessing whether their meds can help with these storms, including, more recently, GlaxoSmithKline, which said this month it had identified a monoclonal antibody from its pipeline, anti-GM-CSF (granulocyte macrophage colony-stimulating factor) otilimab, as a potential treatment for patients who have been hospitalized with severe pulmonary complications related to COVID-19.
The drug was originally being developed in arthritis but is now being expanded in the hope it can help in the pandemic.