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Carlos Buesa's team from Zaragoza will test a new drug on 40 patients from two hospitals in Barcelona and is studying to incorporate another from Zaragoza capital
The team led by Carlos Buesa from Zaragoza, president of the biopharmaceutical company Oryzon Genomics, has started a clinical trial in seriously ill coronavirus patients to tackle one of the main causes of mortality: acute respiratory distress syndrome. The tests will be carried out in two hospitals in Barcelona, the Hebron Valley and the Hospital del Mar. Likewise, there are "serious possibilities" of incorporating patients from a hospital in Zaragoza, with which conversations have already been held.
The hypothesis, Buesa explained, is that vafidemstat, a drug tested in Alzheimer's and multiple sclerosis patients, is capable of reducing the proteins that 'anticipate' the uncontrolled reaction that leads to acute respiratory distress syndrome. This would allow these complications to be treated in the ward before the patient worsens and has to be transferred to the ICU, which would have, according to this Zaragoza scientist, "extraordinary value" from the point of view of public health.
The trial, in which 40 people divided into two groups will participate, has been authorized in record time. Twenty of them will be given the standard palliative medication that is being used in Spanish hospitals to prevent worsening and for the remaining 20, the same combination with the addition of vafidemstat. "Then, the efficacy will be measured at day 20, day 7 and day 14 according to various clinical parameters," he explained.
"The drug would allow complications to be managed in the ward before the patient's health deteriorates"
The biopharmaceutical company claims to be “excited and very hopeful” about this trial. «There is a lot of expectation. “We believe we have a very serious hypothesis,” said Buesa. Regarding its expansion to more hospitals, she admitted that she would "very much like" to include one of the large centers in Zaragoza for a second phase.
The drug has already been tested on a hundred elderly patients with Alzheimer's for six months without any safety problems being recorded. Its effectiveness was also tested in multiple sclerosis patients. In this case, it was shown that in "very hard" models of sclerosis it was capable of reducing the proteins that appear as "heralds" of the uncontrolled reaction that causes respiratory distress.
The deadlines for this new trial will depend, in the first instance, on the recruitment rate. The fact that there are fewer and fewer seriously ill patients will mean that it will take weeks. However, Buesa hopes to have an idea of whether the drug is capable of producing therapeutic improvements "in a matter of months." If the result is positive, Oryzon will "immediately" inform the European Medicines Agency and its American counterpart to request a "conditional accelerated" approval that allows this drug to be used to combat the virus.
Buesa recalled that the current one could mutate in the coming years, which would make the vaccines developed ineffective, a situation that has already occurred with those of the Middle East respiratory syndrome (MERS-CoV).
The treatment that is now being tested could save thousands of lives, since, as the president of Oryzon stressed, a "very high" percentage of deaths from coronavirus have occurred due to the progression of acute respiratory distress syndrome, which ends up producing a failure organic that can lead to respiratory, renal or cardiac failure and cause the death of the patient. The advantage is that, if the hypothesis is proven, this drug could combat both the symptoms of covid-19 and those of its possible future mutations.
