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Despite the urgent danger of antibiotic resistance, investments in European players in biotechnological antibiotics have remained stable. However, the growing awareness of regulation and society could lead to further investments in the years to come.
Over the past decade, pressure has increased on healthcare systems as infectious microbes become increasingly difficult to fight with antibiotics. Certain strains of bacteria, including Clostridium difficile, are seen as urgent threats that require a better range of antibiotic treatments.
There are 43 antibiotics in development around the world, according to a World Health Organization report in April this year examining current antibacterial treatments. However, most of them are derivatives of existing classes of drugs. This increases the likelihood that drug-resistant microbes will develop resistance against newer antibiotics.
“The scientific and medical communities are very worried and have been asking for funds for more than two decades,Said Juanjo Infante, CEO of Spanish vaccine developer VaxDyn. “The problem is serious. “
Over the past two years, the Covid-19 pandemic has had a positive impact on investments in strategies to fight viral infections, including vaccines and diagnostics. However, this is of limited help for companies developing other anti-infective drugs such as antibiotics and antifungals.
“While huge sums of money have been invested in vaccines and antiviral treatments, the funding environment for antibiotics and antifungals has remained relatively stable,Said Aleks Engel, partner of Novo Seeds, the start-up arm of Danish investor Novo Holdings.
Much of the biotech industry is experiencing an investment boom, but the same is not true of European and Israeli biotechs working on treatments for bacterial infections. These players pocketed around 380 million euros in 2018, and this was not matched in the following years. This year seems to want to continue the trend.
This year alone, hot research areas like oncology have generated huge rounds of private funding, like Apollo Therapeutics’ investment of 117 million euros ($ 145 million) in June. Meanwhile, the biggest fundraisers for European companies developing antibacterial approaches barely exceeded € 20m. The most recent entry was a € 17.7million Series A round from Scottish company Enterobiotix, which is developing a microbiome treatment for a range of conditions, including infectious diseases.
Some of the best fundraisers in the European antibiotic resistance area have also faced rough seas.
One example is Polyphor, which put the brakes on two Phase III trials of its antibiotic murepavadin in 2019 over safety concerns. After the failure of its cancer treatment in phase III trials this year, the in a hurry Polyphor this month began preparations for its merger with the American firm Enbiotix.
Meanwhile, Iterum Therapeutics experienced a bump in July this year as the FDA snubbed its antibiotic treatment for urinary tract infections, asking for more clinical evidence of its effectiveness. The company’s stock price fell more than 60% after the news broke and has not recovered since.
One of the main reasons for the sluggishness of investment in antibiotics is that it is seen as a broken market. Healthcare professionals usually use antibiotics sparingly to avoid exposing germs to them and developing resistance to antibiotics. This in turn hurts the producer’s bottom line.
“Since [generic drugs] are very cheap, they will use them first and only then the others,Said Moshik Cohen-Kutner, CEO of Israeli biotech Omnix Medical. “And since it is very expensive to develop a new drug, why should they invest in this kind of field when they can make a lot more money from cancer or autoimmune diseases?“
Without the financial incentive to develop these drugs, the big pharmaceutical companies have gradually abandoned antibiotics. This has a ripple effect on small businesses that aim to weather the crisis, as investors see little way to get a return on their investment.
“You must have signs of effectiveness in humans before [pharma companies] start looking at you”Cohen-Kutner said. “It is very difficult to close that gap because it’s a gap of $ 20 million or $ 30 million. Many companies do not survive this gap. They just can’t raise the money.“
There are many funding organizations that are trying to reduce the risk of antibiotic research, including CARB-X, the NIH, and the Repair Impact Fund from Novo Holdings. Last year, public funding agencies partnered with pharmaceutical companies to launch an 870 million euros ($ 1 billion) RAM action fund, with the aim of bringing two to four new antibiotics to market. by 2030. The fund’s first investments are expected to be announced by the end of the year.
“The problem of antibiotic resistance is much more concentrated today than it was five years ago when we started our development.Said Annette Säfholm, CEO of Gedea Biotech, a Swedish company treating bacterial vaginosis.
“In general, however, given the scale and importance of this issue, current initiatives and funding alternatives are by no means sufficient.“
To mend the broken market, there are movements to reform the way we pay for antibiotics. One common suggestion is the so-called Netflix model, in which an antibiotic developer is paid regardless of the amount of drug used. The UK is leading the charge in this direction, followed closely by Sweden. The EU is considering such an option, while the US is debating this legislation in the form of the Pasteur Law.
“It is important to note that this is not a giveaway to the big pharmaceutical companies because 95% of antimicrobials are developed by small companies.Wrote Stephen Quake, professor of bioengineering at Stanford University, and Sevahn Vorperian, graduate student in his lab, for STAT in June of this year.
There is also growing interest in next-generation technologies that could bypass the antibiotic resistance of invading bacteria. The recent World Health Organization Antibacterial Treatments report for the first time gave comprehensive coverage of alternatives to antibiotics such as bacteria-scavenging viruses, antibody-based drugs and immunotherapies.
Omnix Medical secured NIH grant last month to fund the development of antimicrobial peptide drugs for multidrug-resistant drugs Acinetobacter baumannii. Unlike current antibiotics, peptide drugs are designed to tear apart the protective membrane of bacteria.
“It’s the difference between a physical mechanism of action and a biochemical mechanism, where we inhibit some sort of process within the bacteria that causes them to die.Said Niv Bachnoff, director of safety at Omnix Medical. “This is something that bacteria can overcome very easily. But when you just put holes in them it’s this physical damage they can’t get over. ”
In its quest to treat bacterial vaginosis, Gedea Biotech uses a tablet to restore the acidity of the vagina to a healthy state and promote the growth of beneficial bacteria. In this way, antibiotics – the typical treatment for the disease – could be spared for emergency uses.
“So far we see many initiatives from national and international policy makers to reduce the use of antibiotics or develop new ones,”Säfholm said. “There is not much emphasis on alternative treatments that actually treat infections without antibiotics.. “
While vaccines and viral treatments have been in the spotlight during the Covid-19 pandemic, an indirect consequence of the coronavirus pandemic is that hospitals have become increasingly crowded and more patients are at risk of catching illnesses. antibiotic resistant superbugs. This accelerates the need for new options against them.
What’s more, the astonishing changes in fortunes of the biggest vaccine makers have boosted morale in other areas of infectious disease research.
“Right before the Covid-19 pandemic, we were in a very bad situation. We said, “It won’t work with antibiotics; it becomes very, very difficult to raise money, ‘”Cohen-Kutner said. “The pandemic has been a game-changer because companies like BioNTech and Moderna have made billions in valuations.“
If a glorious return on investment in antibiotics occurs, it will probably be years to wait. The market remains shattered, and much depends on whether it can be fixed through drug price reforms and the adoption of new technologies.
“We kind of solved the anti-infective problem for about 40 years, which was like the golden age.“said Bachnoff.”But since then, it is the descent.“
“We must stop this decline, because otherwise we will find ourselves in the pre-antibiotic era, and it will be messy. “
Cover image of Elena Resko
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