The Swiss company’s long-Covid drug receives approval for research

Nearly three years after the first cases, there is no very effective therapy for severe long-term Covid symptoms. Among other things, hopes are pinned on a drug called BC 007 from the small Swiss company Berlin Cures. The drug aims to neutralize the autoantibodies in certain patients that cause some type of autoimmune disease. These attack the body’s own cells.

It was often hoped that the approval investigation would start soon – now Berlin Cures announces that they have received clearance from the German authorities and ethics committees. “We are pleased with how well things went,” said Ulf Berg, vice-chairman of the board of directors of Berlin Cures, “the authorities immediately recognized the urgency of the situation.” Rainer Boehm, new CEO of Berlin Cures, says the study will start in the second quarter of this year.

The approvals of the other countries where patients are also being recruited are still pending: Switzerland, Spain, Austria and Finland. In total, more than 100 people are participating in the study. One third will receive a placebo, two thirds, 76 people, will receive the drug in two different doses.

Only patients whose infection occurred only three to twelve months ago can participate. “In this window of time, we have the greatest chance of making a difference with the drug,” says Boehm. Because the drug is expected to work less well in long-Covid patients, whose complaints have become chronic. Nevertheless, they must also receive the medicine once it has been approved.

It may take some time: the study results should be available by the end of the year, but then a phase 3 study with significantly more patients should follow. Unless the drug is so effective that emergency approvals are realistic. But Boehm does not want to stir up hope unnecessarily. Boehm, who is a physician and has been with Novartis for 30 years, says, “We probably won’t be able to shorten the approval process.”

The question is whether BC 007 will not be painfully late on the market, provided that the research results are convincing. Because most people have already been infected with Sars-Cov-2 for the first time, and those who developed Long Covid need help now. In the case of re-infections, the risk of developing Long Covid is even lower: a more recent pessimistic study assumes a 28 percent lower risk, others a more significant reduction. “There will be new cases of Long Covid in the coming years,” Boehm is convinced, “and we hope that BC 007 also relieves the symptoms that were infected long ago.” (aargauerzeitung.ch)