Even as the FDA has already approved or authorized several COVID-19 drugs, the search for better therapies is still underway—and despite some high-profile failures, repurposing existing drugs remains a strategy.
Now, three pharma companies have decided to tap their own portfolios in a new clinical trial among hospitalized patients.
Tuesday, Amgen, Takeda and UCB said they have kicked off a so-called adaptive trial to see whether any one of three drugs can rein in the uncontrolled inflammatory responses that afflict some COVID patients.
The three drugs are Amgen’s psoriasis and psoriatic arthritis med Otezla; an intravenous formulation of Takeda’s hereditary angioedema therapy Takhzyro; and UCB’s experimental autoimmune drug zilucoplan.
The trial, dubbed Community, will recruit a wide range of hospitalized patients, from those with mild symptoms all the way up to the point where the patient requires invasive ventilation or extracorporeal membrane oxygenation, commonly known as ECMO.
“By enrolling both hospitalized intensive care unit and non-intensive care unit patients, the trial seeks to yield greater understanding of how therapeutic interventions may be used with hospitalized COVID-19 patients experiencing a range of symptoms,” the companies said.
The three drugmakers are part of the COVID R&D Alliance, a group of more than 20 biopharma firms formed to support drug development efforts in the pandemic. Under that collaboration frame, Takeda and Amgen previously partnered up with AbbVie in the I-SPY COVID study, evaluating Otezla, Takhzyro predecessor Firazyr and AbbVie’s experimental nonalcoholic steatohepatitis drug cenicriviroc in severe COVID patients who require high-flow oxygen but aren't ill enough to need invasive ventilation.
The Community study will evaluate the time to confirmed clinical recovery as the primary endpoint, with death rate, oxygen-free recovery, clinical improvement and fitness for hospital discharge as key secondary endpoints.
Like the National Institutes of Health’s ACTT program, the Community trial also uses an adaptive platform, which allows for assessment of multiple candidates. As the trial moves forward, drugs that do not show benefits will be removed and other therapies, including antiviral, immunomodulating and vascular agents, may enter.
Otezla came in Amgen’s possession recently by way of an FTC-forced sale during Celgene’s merger with Bristol Myers Squibb. Zilucoplan landed at UCB through the Belgium company’s $2.5 billion acquisition of Ra Pharmaceuticals, and it’s in a phase 3 trial in myasthenia gravis patients.
So far, the FDA has officially greenlighted Gilead Sciences’ antiviral Veklury (remdesivir) to treat hospitalized COVID patients, and last month granted Eli Lilly’s arthritis med Olumiant an emergency use authorization to be used alongside the Gilead drug in patients who need oxygen support.
In addition, Lilly’s AbCellera-partnered anti-SARS-CoV-2 antibody bamlanivimab and Regeneron’s antibody cocktail of casirivimab and imdevimab have also scored FDA emergency nods, but only in the outpatient setting.