Posted on Jul 27, 2021 at 8:01 am
It is now well established: our intestinal flora, also called microbiota, is part of the immune system. Each time we take antibiotics (which are antibacterials), they do not pass completely into the bloodstream and residues end up in the intestine where they alter our microbiota (made up of bacteria). Managing to neutralize these unwanted residues is the goal of the French biotech company Da Volterra, which employs 45 people.
It has developed an adsorbent protected by a coating (DAV132) specially designed to disintegrate in the colon where it “captures” the residues of antibiotics. After having tested it on 496 people in six phase I studies and one phase II study, it has just included the first patient of a phase III study, the objective of which is to show that the negative impact of antibiotics on the microbiota and therefore on immunity can be attenuated thanks to its product.
The phase III study which is starting will include 900 patients suffering from acute leukemia, treated by chemotherapy and antibiotics, in around 100 centers around the world. Regulatory agencies in seven countries including France, Spain, Germany and Denmark have given the green light. “Protecting the microbiota of patients with acute myeloid leukemia is important because their immune system is severely weakened by chemotherapy. And those whose microbiota is disrupted have more life-threatening complications and a lower survival rate ”, explains Florence Séjourné, who directs Da Volterra.
The primary endpoint will be whether or not Clostridium difficile infections occur, a serious and life-threatening complication caused by disruption of the gut microbiota. The study will also evaluate the effectiveness of DAV132 in protecting the diversity of the microbiota, preventing intestinal colonization by potentially pathogenic bacteria, preventing bacteremia and improving overall survival.
Major medical need
Da Volterra had already carried out a meta-analysis (exploitation of various clinical studies already carried out) on more than 2,200 patients suffering from metastatic lung cancer treated by immunotherapy (Keytruda from Merck-MSD). Those who had to take antibiotics died on average 7 months earlier than others. Four other studies carried out since had reached similar conclusions.
It took a dozen years for the company to reach this decisive step because if the financing of biotechs is difficult in Europe, it is even more the case for everything related to antibiotics, a field deemed unprofitable. , although this is a major medical need.
The European institutions are trying to give a boost to the biotechs who venture there, without them Da Volterra would not have been able to finance the clinical development of DAV132. It was one of the two products selected by the New Drugs for Bad Bugs (ND4BB) program launched in 2013, then Da Volterra received 20 million euros from the European Investment Bank in 2017-2018 and the phase study III which is starting up is financed to the tune of 18 million euros by the COMBACTE-NET consortium supported by the Innovative Medicines Initiative (IMI) and the large pharmaceutical companies.