The drug industry has come together in unprecedented collaborative efforts to tackle COVID-19. Now, as part of an R&D alliance, three big drugmakers are running a joint clinical trial to see whether their products can improve outcomes for severely ill patients.
A recently launched clinical program, dubbed I-SPY, will test Amgen’s psoriasis med Otezla, Takeda’s hereditary angioedema therapy Firazyr and AbbVie’s experimental nonalcoholic steatohepatitis drug cenicriviroc to see if they can tamp down potentially life-threatening immune overreaction seen in some serious COVID-19 patients, the three companies said Monday.
The primary endpoint of the study is time for severe COVID-19 patients on high-flow oxygen support to improve at least 1 point on an 8-point World Health Organization ordinal COVID status scale for at least 48 hours.
Rather than each company operating its own trial, the I-SPY study, by way of an “adaptive platform,” allows for multiple trial arms that can test several potential COVID-19 therapies simultaneously and modify protocols in real-time based on observed outcomes, thereby reducing the number of participants and time required to evaluate drugs.
Under the “adaptive platform,” drugs can proceed in the trial if early signs are positive. If the signal for improvement is strong, a drug may become the new standard of care, and without the trial stopping, new therapies could be added onto the new backbone regimen as the trial moves forward.
AbbVie, Amgen and Takeda recently helped form the COVID R&D Alliance, a group of more than 20 biopharma companies working to accelerate the development of drugs against COVID-19 and related symptoms. The new study is a collaboration between the group, Quantum Leap Healthcare Collaborative—designer of the adaptive platform—and the FDA. Quantum Leap will utilize its clinical trial network of more than 20 sites to help run the study.
While the I-SPY COVID trial will have no more than four arms being studied at any one time, the goal is to evaluate 10 to 20 agents over one year, depending on the progress of the disease, Quantum Leap said in a statement in April when launching the initiative.
In I-SPY, each drug will be paired with standard of care, which now includes Gilead Sciences’ remdesivir and old corticosteroid dexamethasone, according to Reuters. In the ACTT-1 trial, remdesivir showed it could cut COVID-19 patients’ recovery time by four days, or 31%, compared with placebo. In the Recovery study by U.K. researchers, dexamethasone reduced the 28-day death rate by 35% in severely ill patients requiring ventilator support.
Each of the three companies has a theory as to why its drug might work. Otezla inhibits PDE4, which is thought to indirectly modulate the production of inflammatory molecules. Firazyr works in acute HAE attack by inhibiting the receptor of inflammatory molecule bradykinin. Cenicriviroc is a blocker of chemokine receptors CCR2 and CCR5, which are also linked to acute respiratory distress syndrome in COVID-19.
Other drugs have also been tested for their anti-inflammatory ability in COVID-19. For example, Roche’s Actemra and Sanofi and Regeneron’s rival IL-6 inhibitor Kevzara have failed in their separate trials, though a study pairing Actemra and remdesivir remains ongoing. The NIH is combining Eli Lilly’s arthritis drug Olumiant with remdesivir in the ACTT-2 trial, meanwhile, and Novartis is running a study of its own Incyte-partnered JAK inhibitor Jakafi.
By: Angus Liu
Source: Fierce Pharma
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